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Metformin in Diabetic Patients Undergoing Coronary Angiography (NO-STOP)

Primary Purpose

Diabetes Mellitus, Coronary Artery Disease, Lactic Acidosis With Diabetes Mellitus

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Sponsored by
Humanitas Hospital, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring metformin, coronary angiography, diabetes mellitus, lactic acidosis

Eligibility Criteria

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

Inclusion Criteria:

  • Diabetic patients treated with metformin undergoing coronary angiography.

Exclusion Criteria:

  • Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 * estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2).
  • Moderate to severe impairment of renal function (eGFR<45 ml/min).
  • Moderate to severe impairment of liver function (Child-Pugh class B or C).
  • Severely impaired left ventricular ejection fraction (LVEF <35%).
  • Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
  • Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
  • Patients scheduled for cardiac surgery in the following 5 days.
  • Inability to provide informed consent.

Sites / Locations

  • Humanitas Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin continuation

Arm Description

Outcomes

Primary Outcome Measures

Increase in lactate of 20%
Lactate will be measured from a venous sampling at three different time points, before coronary angiography, the day after (not mandatory) and 3 days after coronary angiography

Secondary Outcome Measures

Contrast-associated acute kidney injury after coronary angiography.
Contrast-associated acute kidney injury was defined according to the KDIGO definition: increase in serum creatinine of 0.3 mg/dl within 48 hours from coronary angiography or >50% within 7 days (if creatinine after 7 days is available) or urine output of <0.5 ml/kg/hour for at least 6 hours
Metformin associated lactic acidosis
Lactic acidosis was defined as pH less than or equal to 7.35 and lactatemia greater than 2.2 mmol/L

Full Information

First Posted
January 26, 2021
Last Updated
April 11, 2022
Sponsor
Humanitas Hospital, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT04766008
Brief Title
Metformin in Diabetic Patients Undergoing Coronary Angiography
Acronym
NO-STOP
Official Title
Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humanitas Hospital, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately before angiography and withhold metformin if renal function deteriorates. The aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.
Detailed Description
The study is designed as an open-label (both physician and participant know that metformin will not be discontinued before PCI and in the following 48 hours), prospective, single arm study. In our historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l. A total of 150 patients will be enrolled. Patients with any deviations from the study protocol will be enrolled in a parallel observational registry. The study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. The total duration of participation in the study for each participant is approximately 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Coronary Artery Disease, Lactic Acidosis With Diabetes Mellitus, Contrast-induced Nephropathy, Metformin Associated Lactic Acidosis
Keywords
metformin, coronary angiography, diabetes mellitus, lactic acidosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin continuation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.
Primary Outcome Measure Information:
Title
Increase in lactate of 20%
Description
Lactate will be measured from a venous sampling at three different time points, before coronary angiography, the day after (not mandatory) and 3 days after coronary angiography
Time Frame
From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography
Secondary Outcome Measure Information:
Title
Contrast-associated acute kidney injury after coronary angiography.
Description
Contrast-associated acute kidney injury was defined according to the KDIGO definition: increase in serum creatinine of 0.3 mg/dl within 48 hours from coronary angiography or >50% within 7 days (if creatinine after 7 days is available) or urine output of <0.5 ml/kg/hour for at least 6 hours
Time Frame
From 0 to 7 days after coronary angiography
Title
Metformin associated lactic acidosis
Description
Lactic acidosis was defined as pH less than or equal to 7.35 and lactatemia greater than 2.2 mmol/L
Time Frame
At 24 and 72 hours after coronary angiography
Other Pre-specified Outcome Measures:
Title
Death
Description
All cause mortality
Time Frame
Within 30 days after the index coronary angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetic patients treated with metformin undergoing coronary angiography. Exclusion Criteria: Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 * estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2). Moderate to severe impairment of renal function (eGFR<45 ml/min). Moderate to severe impairment of liver function (Child-Pugh class B or C). Severely impaired left ventricular ejection fraction (LVEF <35%). Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction). Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4). Patients scheduled for cardiac surgery in the following 5 days. Inability to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio Stefanini, MD, PhD
Phone
+390282247384
Email
giulio.stefanini@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Chiarito, MD
Phone
+390282247009
Email
mauro.chiarito@humanitas.it
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Stefanini, Prof
Phone
0282247384
Email
giulio.stefanini@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Mauro Chiarito, MD
First Name & Middle Initial & Last Name & Degree
Giulio Stefanini, Prof
First Name & Middle Initial & Last Name & Degree
Jorge Sanz-Sanchez, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data that support the findings of this study will be available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
19797290
Citation
Pfisterer ME, Zellweger MJ. Therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Oct 1;361(14):1407; author reply 1409-10. doi: 10.1056/NEJMc091419. No abstract available.
Results Reference
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PubMed Identifier
8569826
Citation
Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.
Results Reference
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PubMed Identifier
21959259
Citation
Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175.
Results Reference
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PubMed Identifier
15808754
Citation
Timmer JR, Ottervanger JP, de Boer MJ, Dambrink JH, Hoorntje JC, Gosselink AT, Suryapranata H, Zijlstra F, van 't Hof AW; Zwolle Myocardial Infarction Study Group. Hyperglycemia is an important predictor of impaired coronary flow before reperfusion therapy in ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2005 Apr 5;45(7):999-1002. doi: 10.1016/j.jacc.2004.12.050.
Results Reference
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PubMed Identifier
31553855
Citation
Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. Reply. N Engl J Med. 2019 Sep 26;381(13):1296-1297. doi: 10.1056/NEJMc1908879. No abstract available.
Results Reference
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PubMed Identifier
30667361
Citation
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534. doi: 10.4244/EIJY19M01_01. No abstract available.
Results Reference
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PubMed Identifier
15338847
Citation
Parra D, Legreid AM, Beckey NP, Reyes S. Metformin monitoring and change in serum creatinine levels in patients undergoing radiologic procedures involving administration of intravenous contrast media. Pharmacotherapy. 2004 Aug;24(8):987-93. doi: 10.1592/phco.24.11.987.36131. Erratum In: Pharmacotherapy. 2004 Oct;24(10):1489.
Results Reference
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PubMed Identifier
9630271
Citation
Nawaz S, Cleveland T, Gaines PA, Chan P. Clinical risk associated with contrast angiography in metformin treated patients: a clinical review. Clin Radiol. 1998 May;53(5):342-4. doi: 10.1016/s0009-9260(98)80005-6.
Results Reference
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PubMed Identifier
17692741
Citation
Laskey WK, Jenkins C, Selzer F, Marroquin OC, Wilensky RL, Glaser R, Cohen HA, Holmes DR Jr; NHLBI Dynamic Registry Investigators. Volume-to-creatinine clearance ratio: a pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am Coll Cardiol. 2007 Aug 14;50(7):584-90. doi: 10.1016/j.jacc.2007.03.058. Epub 2007 Jul 30.
Results Reference
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Metformin in Diabetic Patients Undergoing Coronary Angiography

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