search
Back to results

Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients (DAPAMICRO)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Dapagliflozin 10 mg Tab
Placebo
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Dapagliflozin, Physiological Effects of Drugs, Coronary Artery Disease, Microcirculation, Fraction Flow Reserve, Index of Microcirculatory Resistance, Coronary Flow Reserve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes mellitus (T2DM) patients presenting with stable angina and a clinical indication for cardiac catheterization
  • T2DM patients with non ST elevation myocardial infarction (NSTEMI) or unstable angina referred for cardiac catheterization
  • Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred
  • Agreement to practice an acceptable method of birth control for women of childbearing potential
  • Signed patient informed consent

Exclusion Criteria:

  • Age < 18 years old
  • T2DM patients presenting with ST elevation myocardial infarction (STEMI)
  • Pregnancy or breastfeeding
  • Body mass index ≥45 kg/m2
  • Creatinine clearance ≤45 ml/min/1.73 m2 (as calculated by Modification of Diet in Renal Disease Study (MDRD ) formula for estimated Glomerular filtration rate (GFR))
  • Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase
  • Uncontrolled hyperglycemia with glucose >240 mg/dL after an overnight fast
  • Stroke, or transient ischemic attack at presentation and up to 2 months prior to informed consent
  • Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
  • Any uncontrolled endocrine disorder except type 2 diabetes
  • Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  • Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight
  • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
  • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  • Planned cardiac surgery or angioplasty within 3 months
  • Any clinical condition that would jeopardize patient safety while participating in this clinical trial
  • Life expectancy < 3 years

Sites / Locations

  • CHU Saint PierreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

dapagliflozin group

Arm Description

The patient will be treated in standard of care for type 2 diabetic mellitus and will receive a placebo (1 tablet) administered orally daily during 24 weeks

The patient will be treated in standard of care for type 2 diabetic mellitus and will receive Dapagliflozin 10 mg (1 tablet) administered orally daily during 24 weeks

Outcomes

Primary Outcome Measures

the longitudinal change of the Fractional Flow Reserve (FRR)
The longitudinal change (Δ) of FFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. In the presence of coronary lesions, the degree of percent diameter stenosis will be measured by quantitative coronary angiography and their hemodynamic significance will be evaluated by measuring fractional flow reserve (FFR). According to the guidelines for myocardial revascularisation, only the lesions that have an FFR value equal or less than 0.8 will be treated by coronary angioplasty . In case of angioplasty, FFR will be also measured immediately after successful implantation of the coronary stent.
the longitudinal change of the Coronary flow reserve (CFR)
The longitudinal change (Δ) of CFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. Coronary flow reserve (CFR) will be measured in the vessels of interest, where FFR was measured.
the longitudinal change of the Index of Microvascular Resistance (IMR).
The longitudinal change (Δ) of IMR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. The Index of Microvascular Resistance (IMR) will be measured in the vessels of interest, where FFR was measured.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
August 30, 2022
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT05392959
Brief Title
Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients
Acronym
DAPAMICRO
Official Title
Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cardiovascular events remain a major driver of morbidity and mortality in patients with type 2 diabetes mellitus. Diffuse coronary atherosclerosis, combined with impairment of the microcirculation are frequent even in asymptomatic patients and can lead to unfavourable outcomes. In recent years, novel classes of antidiabetic drugs have been introduced, with salutary effects on cardiovascular outcomes of diabetic patients. The sodium-glucose linked transporter 2 (SGLT2) inhibitors - gliflozins - bind to the SGLT2 receptors of the proximal tubule of the nephron and cause glycosuria. They have been shown to have favourable cardiovascular effects by reducing deaths from cardiovascular causes in type 2 diabetic patients. Moreover, dapagliflozin reduces hospitalisation for heart failure in type 2 diabetic heart failure patients with and without reduced ejection fraction and reduces cardiovascular death and all causes mortality in those with reduced ejection fraction. It is currently unknown if this is mediated by improvement of coronary physiology both at the level of the epicardial coronary arteries as well as the coronary microcirculation. The purpose of the study is to explore the impact of dapagliflozin on the coronary and microcirculatory function of type 2 diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Dapagliflozin, Physiological Effects of Drugs, Coronary Artery Disease, Microcirculation, Fraction Flow Reserve, Index of Microcirculatory Resistance, Coronary Flow Reserve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The patient will be treated in standard of care for type 2 diabetic mellitus and will receive a placebo (1 tablet) administered orally daily during 24 weeks
Arm Title
dapagliflozin group
Arm Type
Experimental
Arm Description
The patient will be treated in standard of care for type 2 diabetic mellitus and will receive Dapagliflozin 10 mg (1 tablet) administered orally daily during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 mg Tab
Other Intervention Name(s)
Forxiga®
Intervention Description
Dapagliflozin 10 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for dapagliflozin film-coated tablets 10 mg
Primary Outcome Measure Information:
Title
the longitudinal change of the Fractional Flow Reserve (FRR)
Description
The longitudinal change (Δ) of FFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. In the presence of coronary lesions, the degree of percent diameter stenosis will be measured by quantitative coronary angiography and their hemodynamic significance will be evaluated by measuring fractional flow reserve (FFR). According to the guidelines for myocardial revascularisation, only the lesions that have an FFR value equal or less than 0.8 will be treated by coronary angioplasty . In case of angioplasty, FFR will be also measured immediately after successful implantation of the coronary stent.
Time Frame
up to 6 months
Title
the longitudinal change of the Coronary flow reserve (CFR)
Description
The longitudinal change (Δ) of CFR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. Coronary flow reserve (CFR) will be measured in the vessels of interest, where FFR was measured.
Time Frame
up to 6 months
Title
the longitudinal change of the Index of Microvascular Resistance (IMR).
Description
The longitudinal change (Δ) of IMR is defined as the value at follow-up (6 months) minus the value at baseline. The complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform. The Index of Microvascular Resistance (IMR) will be measured in the vessels of interest, where FFR was measured.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes mellitus (T2DM) patients presenting with stable angina and a clinical indication for cardiac catheterization T2DM patients with non ST elevation myocardial infarction (NSTEMI) or unstable angina referred for cardiac catheterization Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred Agreement to practice an acceptable method of birth control for women of childbearing potential Signed patient informed consent Exclusion Criteria: Age < 18 years old T2DM patients presenting with ST elevation myocardial infarction (STEMI) Pregnancy or breastfeeding Body mass index ≥45 kg/m2 Creatinine clearance ≤45 ml/min/1.73 m2 (as calculated by Modification of Diet in Renal Disease Study (MDRD ) formula for estimated Glomerular filtration rate (GFR)) Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase Uncontrolled hyperglycemia with glucose >240 mg/dL after an overnight fast Stroke, or transient ischemic attack at presentation and up to 2 months prior to informed consent Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake Any uncontrolled endocrine disorder except type 2 diabetes Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption Planned cardiac surgery or angioplasty within 3 months Any clinical condition that would jeopardize patient safety while participating in this clinical trial Life expectancy < 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panagiotis Xaplanteris, MD, PhD
Phone
+3225353963
Email
panagiotis.xaplanteris@stpierre-bru.be
First Name & Middle Initial & Last Name or Official Title & Degree
Katty Renard
Phone
+3225354856
Email
katty.renard@stpierre-bru.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Xaplanteris, MD, PhD
Organizational Affiliation
panagiotis.xaplanteris@stpierre-bru.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint Pierre
City
Brussels
State/Province
Bruxelles-Capitale, Région de;Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Xaplanteris, MD, PhD
Phone
+3225353963
Email
panagiotis.xaplanteris@stpierre-bru.be
First Name & Middle Initial & Last Name & Degree
Katty Renard
Phone
+3225354856
Email
katty.renard@stpierre-bru.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20566676
Citation
Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.
Results Reference
background
PubMed Identifier
25538310
Citation
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.
Results Reference
background
PubMed Identifier
27941935
Citation
DeFronzo RA, Norton L, Abdul-Ghani M. Renal, metabolic and cardiovascular considerations of SGLT2 inhibition. Nat Rev Nephrol. 2017 Jan;13(1):11-26. doi: 10.1038/nrneph.2016.170. Epub 2016 Dec 12.
Results Reference
background
PubMed Identifier
20609968
Citation
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
Results Reference
background
PubMed Identifier
27440828
Citation
Wilding JP, Rajeev SP, DeFronzo RA. Positioning SGLT2 Inhibitors/Incretin-Based Therapies in the Treatment Algorithm. Diabetes Care. 2016 Aug;39 Suppl 2:S154-64. doi: 10.2337/dcS15-3005.
Results Reference
background
PubMed Identifier
27208375
Citation
Abdul-Ghani M, Del Prato S, Chilton R, DeFronzo RA. SGLT2 Inhibitors and Cardiovascular Risk: Lessons Learned From the EMPA-REG OUTCOME Study. Diabetes Care. 2016 May;39(5):717-25. doi: 10.2337/dc16-0041.
Results Reference
background
PubMed Identifier
29306791
Citation
Zhou H, Wang S, Zhu P, Hu S, Chen Y, Ren J. Empagliflozin rescues diabetic myocardial microvascular injury via AMPK-mediated inhibition of mitochondrial fission. Redox Biol. 2018 May;15:335-346. doi: 10.1016/j.redox.2017.12.019. Epub 2017 Dec 30.
Results Reference
background
PubMed Identifier
28231831
Citation
Ott C, Jumar A, Striepe K, Friedrich S, Karg MV, Bramlage P, Schmieder RE. A randomised study of the impact of the SGLT2 inhibitor dapagliflozin on microvascular and macrovascular circulation. Cardiovasc Diabetol. 2017 Feb 23;16(1):26. doi: 10.1186/s12933-017-0510-1.
Results Reference
background
PubMed Identifier
28254770
Citation
van Bommel EJM, Muskiet MHA, Tonneijck L, Kramer MHH, Nieuwdorp M, van Raalte DH. SGLT2 Inhibition in the Diabetic Kidney-From Mechanisms to Clinical Outcome. Clin J Am Soc Nephrol. 2017 Apr 3;12(4):700-710. doi: 10.2215/CJN.06080616. Epub 2017 Mar 2.
Results Reference
background
PubMed Identifier
25488697
Citation
Scheen AJ. Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs. 2015 Jan;75(1):33-59. doi: 10.1007/s40265-014-0337-y.
Results Reference
background
PubMed Identifier
30415602
Citation
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
Results Reference
background
PubMed Identifier
30882238
Citation
Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.
Results Reference
background
PubMed Identifier
25173601
Citation
Kolh P, Windecker S, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; European Society of Cardiology Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; EACTS Clinical Guidelines Committee; Sousa Uva M, Achenbach S, Pepper J, Anyanwu A, Badimon L, Bauersachs J, Baumbach A, Beygui F, Bonaros N, De Carlo M, Deaton C, Dobrev D, Dunning J, Eeckhout E, Gielen S, Hasdai D, Kirchhof P, Luckraz H, Mahrholdt H, Montalescot G, Paparella D, Rastan AJ, Sanmartin M, Sergeant P, Silber S, Tamargo J, ten Berg J, Thiele H, van Geuns RJ, Wagner HO, Wassmann S, Wendler O, Zamorano JL; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions. 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg. 2014 Oct;46(4):517-92. doi: 10.1093/ejcts/ezu366. Epub 2014 Aug 29. No abstract available.
Results Reference
background
PubMed Identifier
4808557
Citation
Gould KL, Lipscomb K, Hamilton GW. Physiologic basis for assessing critical coronary stenosis. Instantaneous flow response and regional distribution during coronary hyperemia as measures of coronary flow reserve. Am J Cardiol. 1974 Jan;33(1):87-94. doi: 10.1016/0002-9149(74)90743-7. No abstract available.
Results Reference
background
PubMed Identifier
14972422
Citation
Barbato E, Aarnoudse W, Aengevaeren WR, Werner G, Klauss V, Bojara W, Herzfeld I, Oldroyd KG, Pijls NH, De Bruyne B; Week 25 study group. Validation of coronary flow reserve measurements by thermodilution in clinical practice. Eur Heart J. 2004 Feb;25(3):219-23. doi: 10.1016/j.ehj.2003.11.009.
Results Reference
background
PubMed Identifier
21126613
Citation
Cortigiani L, Rigo F, Gherardi S, Galderisi M, Bovenzi F, Picano E, Sicari R. Prognostic effect of coronary flow reserve in women versus men with chest pain syndrome and normal dipyridamole stress echocardiography. Am J Cardiol. 2010 Dec 15;106(12):1703-8. doi: 10.1016/j.amjcard.2010.08.011.
Results Reference
background
PubMed Identifier
22340827
Citation
Johnson NP, Kirkeeide RL, Gould KL. Is discordance of coronary flow reserve and fractional flow reserve due to methodology or clinically relevant coronary pathophysiology? JACC Cardiovasc Imaging. 2012 Feb;5(2):193-202. doi: 10.1016/j.jcmg.2011.09.020.
Results Reference
background
PubMed Identifier
11208673
Citation
Meuwissen M, Chamuleau SA, Siebes M, Schotborgh CE, Koch KT, de Winter RJ, Bax M, de Jong A, Spaan JA, Piek JJ. Role of variability in microvascular resistance on fractional flow reserve and coronary blood flow velocity reserve in intermediate coronary lesions. Circulation. 2001 Jan 16;103(2):184-7. doi: 10.1161/01.cir.103.2.184.
Results Reference
background
PubMed Identifier
8462157
Citation
Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.
Results Reference
background
PubMed Identifier
8124786
Citation
De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
Results Reference
background
PubMed Identifier
8141866
Citation
Topol EJ, Ellis SG, Cosgrove DM, Bates ER, Muller DW, Schork NJ, Schork MA, Loop FD. Analysis of coronary angioplasty practice in the United States with an insurance-claims data base. Circulation. 1993 May;87(5):1489-97. doi: 10.1161/01.cir.87.5.1489.
Results Reference
background
PubMed Identifier
11705815
Citation
De Bruyne B, Hersbach F, Pijls NH, Bartunek J, Bech JW, Heyndrickx GR, Gould KL, Wijns W. Abnormal epicardial coronary resistance in patients with diffuse atherosclerosis but "Normal" coronary angiography. Circulation. 2001 Nov 13;104(20):2401-6. doi: 10.1161/hc4501.099316.
Results Reference
background
PubMed Identifier
8509531
Citation
De Bruyne B, Pijls NH, Paulus WJ, Vantrimpont PJ, Sys SU, Heyndrickx GR. Transstenotic coronary pressure gradient measurement in humans: in vitro and in vivo evaluation of a new pressure monitoring angioplasty guide wire. J Am Coll Cardiol. 1993 Jul;22(1):119-26. doi: 10.1016/0735-1097(93)90825-l.
Results Reference
background
PubMed Identifier
19144937
Citation
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
Results Reference
background
PubMed Identifier
25176289
Citation
De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465.
Results Reference
background
PubMed Identifier
8637515
Citation
Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
Results Reference
background
PubMed Identifier
7586302
Citation
Pijls NH, Van Gelder B, Van der Voort P, Peels K, Bracke FA, Bonnier HJ, el Gamal MI. Fractional flow reserve. A useful index to evaluate the influence of an epicardial coronary stenosis on myocardial blood flow. Circulation. 1995 Dec 1;92(11):3183-93. doi: 10.1161/01.cir.92.11.3183.
Results Reference
background
PubMed Identifier
11447079
Citation
De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. Circulation. 2001 Jul 10;104(2):157-62. doi: 10.1161/01.cir.104.2.157.
Results Reference
background
PubMed Identifier
29785878
Citation
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
Results Reference
background
PubMed Identifier
12821539
Citation
Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23. Erratum In: Circulation. 2003 Dec 23;108(25):3165.
Results Reference
background
PubMed Identifier
23681065
Citation
De Bruyne B, Barbato E. Quantitative assessment of the coronary microvasculature: new tools for the black box. Circulation. 2013 Jun 18;127(24):2378-9. doi: 10.1161/CIRCULATIONAHA.113.003361. Epub 2013 May 16. No abstract available.
Results Reference
background
PubMed Identifier
23681066
Citation
Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
Results Reference
background
PubMed Identifier
15466646
Citation
Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.
Results Reference
background
PubMed Identifier
22874078
Citation
Ng MK, Yong AS, Ho M, Shah MG, Chawantanpipat C, O'Connell R, Keech A, Kritharides L, Fearon WF. The index of microcirculatory resistance predicts myocardial infarction related to percutaneous coronary intervention. Circ Cardiovasc Interv. 2012 Aug 1;5(4):515-22. doi: 10.1161/CIRCINTERVENTIONS.112.969048. Epub 2012 Aug 8.
Results Reference
background
PubMed Identifier
25256535
Citation
Hennigan B, Layland J, Fearon WF, Oldroyd KG. Fractional flow reserve and the index of microvascular resistance in patients with acute coronary syndromes. EuroIntervention. 2014 Aug;10 Suppl T:T55-63. doi: 10.4244/EIJV10STA10.
Results Reference
background
PubMed Identifier
29769166
Citation
Xaplanteris P, Ntalianis A, De Bruyne B, Strisciuglio T, Pellicano M, Ciccarelli G, Milkas A, Barbato E. Coronary lesion progression as assessed by fractional flow reserve (FFR) and angiography. EuroIntervention. 2018 Oct 20;14(8):907-914. doi: 10.4244/EIJ-D-17-00872.
Results Reference
background
PubMed Identifier
26400825
Citation
Zimmermann FM, Ferrara A, Johnson NP, van Nunen LX, Escaned J, Albertsson P, Erbel R, Legrand V, Gwon HC, Remkes WS, Stella PR, van Schaardenburgh P, Bech GJ, De Bruyne B, Pijls NH. Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial. Eur Heart J. 2015 Dec 1;36(45):3182-8. doi: 10.1093/eurheartj/ehv452. Epub 2015 Sep 23.
Results Reference
background

Learn more about this trial

Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients

We'll reach out to this number within 24 hrs