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Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia (RAIN FLOW)

Primary Purpose

Coronary Microvascular Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Drug-mediated hyperemia
Flow-mediated hyperemia
Sponsored by
Fundación EPIC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Microvascular Disease focused on measuring Coronary Microvascular Disease, Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  1. ST elevation myocardial infarction Killip I <12 hours since symptoms onset.
  2. ST elevation > 2 mm anterior leads or > 1 mm inferior or lateral leads.
  3. Sustained slow coronary flow (TIMI flow 0-2) for at least 30 seconds after stent implantation or stent post-dilatation.

Exclusion Criteria:

  1. Previous myocardial infarction in the culprit artery
  2. Previous stroke
  3. Advanced kidney disease (creatinine clearance <30 ml / min).
  4. Active bleeding
  5. Allergy to contrast, nitroprussiate or adenosine.
  6. Culprit lesion in coronary bypass, left main coronary artery or stent thrombosis
  7. Macroscopic thrombus embolization in the infarct-related artery

Sites / Locations

  • Hospital Universitari de Bellvitge
  • Hospital del Mar
  • Hospital Clínic de Barcelona
  • Hospital Universitario Puerta del Mar
  • Hospital La Princesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Drug-mediated hyperemia

Flow-mediated hyperemia

Arm Description

Patients presenting with slow flow after PPCI undergo to at least 200 mcg of intracoronary nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes

Patients presenting with slow flow after PPCI undergo to controlled saline intracoronary infusion by a dedicated microcatheter (RayFlow) at 20 ml/min during 2 minutes

Outcomes

Primary Outcome Measures

Angiographic TIMI frame count
Cine-fluoroscopic recording of the infarct-related artery (IRA) at 30 frames/second and off-line core-laboratory assessment of the number of cineframes needed for dye to reach standardized distal landmarks is the coprimary endpoint. Long TIMI frame counts are indicative of slow coronary flow. Previous studies showed TIMI frame counts of 30 (SD 12) after nitroprussiate in slow flow STEMI patients. The present study is powered to assess 25 percent difference between study groups (80 percent power and 5 percent alfa error).
Minimal microcirculatory resistance (MMR)
MMR is assessed by intracoronary thermodilution with a dedicated pressure wire and microcatheter (RayFlow, Hexacath) during saline infusion at 20 ml/min. MMR is measured offline by the core-laboratory at 20 seconds of the saline infusion in the standard medical treatment group and at 2 minutes and 20 seconds in the experimental group. According to previous studies, MMR was 537 Wood units (SD 289). The present study is powered to assess 30 percent difference between study groups after study intervention (80 percent power and 5 percent alfa error).
Comparison of the MMR in the experimental group during the two-minutes saline infusion
Experimental treatment with saline infusion via microcatheter is performed continuously recording the pressure and temperature values of the culprit artery. Off-line core-laboratory assessment of the MMR will be performed at 20 seconds and at 2 minutes of the saline infusion.
Comparison of the Absolute coronary flow between the study groups.
Absolute coronary flow is performed simultaneously with the MMR. This value shows the coronary blood flow of the culprit artery during maximal hyperemia.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2020
Last Updated
November 9, 2022
Sponsor
Fundación EPIC
Collaborators
Barcicore-Lab
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1. Study Identification

Unique Protocol Identification Number
NCT04685941
Brief Title
Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Acronym
RAIN FLOW
Official Title
Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación EPIC
Collaborators
Barcicore-Lab

4. Oversight

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

5. Study Description

Brief Summary
A total of 100 patients with ST-elevation myocardial infarction (STEMI) presenting slow-flow after primary-percutaneous coronary intervention (PPCI) will be randomized to pharmacologic treatment with hyperemic drugs versus flow-mediated hyperemia.
Detailed Description
Slow-flow phenomena is observed around 15% of patients undergoing PPCI and has been associated with poor prognosis. Hyperemic drugs, such as nitroprussiate and adenosine, have not yet demonstrated to reduce the infarct size and prognosis in patients with slow flow. Controlled flow-mediated hyperemia using a dedicated catheter for intracoronary saline infusion has been shown to stimulate microcirculatory vasodilatation in stable patients similarly as hyperemic drugs. The aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after PPCI, as assessed by intracoronary thermo-dilution, treated with standard pharmacologic hyperemia versus flow-mediated hyperemia; and to compare the angiographic TIMI frame count after treatment of slow flow phenomena with the two investigated strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Disease, Myocardial Infarction
Keywords
Coronary Microvascular Disease, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-mediated hyperemia
Arm Type
Other
Arm Description
Patients presenting with slow flow after PPCI undergo to at least 200 mcg of intracoronary nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes
Arm Title
Flow-mediated hyperemia
Arm Type
Experimental
Arm Description
Patients presenting with slow flow after PPCI undergo to controlled saline intracoronary infusion by a dedicated microcatheter (RayFlow) at 20 ml/min during 2 minutes
Intervention Type
Drug
Intervention Name(s)
Drug-mediated hyperemia
Intervention Description
Intracoronary bolus of at least 200 mcg of nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes. Operators are allowed to combine both drugs.
Intervention Type
Other
Intervention Name(s)
Flow-mediated hyperemia
Intervention Description
Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.
Primary Outcome Measure Information:
Title
Angiographic TIMI frame count
Description
Cine-fluoroscopic recording of the infarct-related artery (IRA) at 30 frames/second and off-line core-laboratory assessment of the number of cineframes needed for dye to reach standardized distal landmarks is the coprimary endpoint. Long TIMI frame counts are indicative of slow coronary flow. Previous studies showed TIMI frame counts of 30 (SD 12) after nitroprussiate in slow flow STEMI patients. The present study is powered to assess 25 percent difference between study groups (80 percent power and 5 percent alfa error).
Time Frame
2 minutes
Title
Minimal microcirculatory resistance (MMR)
Description
MMR is assessed by intracoronary thermodilution with a dedicated pressure wire and microcatheter (RayFlow, Hexacath) during saline infusion at 20 ml/min. MMR is measured offline by the core-laboratory at 20 seconds of the saline infusion in the standard medical treatment group and at 2 minutes and 20 seconds in the experimental group. According to previous studies, MMR was 537 Wood units (SD 289). The present study is powered to assess 30 percent difference between study groups after study intervention (80 percent power and 5 percent alfa error).
Time Frame
2 minutes
Title
Comparison of the MMR in the experimental group during the two-minutes saline infusion
Description
Experimental treatment with saline infusion via microcatheter is performed continuously recording the pressure and temperature values of the culprit artery. Off-line core-laboratory assessment of the MMR will be performed at 20 seconds and at 2 minutes of the saline infusion.
Time Frame
2 minutes
Title
Comparison of the Absolute coronary flow between the study groups.
Description
Absolute coronary flow is performed simultaneously with the MMR. This value shows the coronary blood flow of the culprit artery during maximal hyperemia.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ST elevation myocardial infarction Killip I <12 hours since symptoms onset. ST elevation > 2 mm anterior leads or > 1 mm inferior or lateral leads. Sustained slow coronary flow (TIMI flow 0-2) for at least 30 seconds after stent implantation or stent post-dilatation. Exclusion Criteria: Previous myocardial infarction in the culprit artery Previous stroke Advanced kidney disease (creatinine clearance <30 ml / min). Active bleeding Allergy to contrast, nitroprussiate or adenosine. Culprit lesion in coronary bypass, left main coronary artery or stent thrombosis Macroscopic thrombus embolization in the infarct-related artery
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20118156
Citation
Ndrepepa G, Tiroch K, Keta D, Fusaro M, Seyfarth M, Pache J, Mehilli J, Schomig A, Kastrati A. Predictive factors and impact of no reflow after primary percutaneous coronary intervention in patients with acute myocardial infarction. Circ Cardiovasc Interv. 2010 Feb 1;3(1):27-33. doi: 10.1161/CIRCINTERVENTIONS.109.896225. Epub 2010 Jan 26.
Results Reference
background
PubMed Identifier
17398183
Citation
Airoldi F, Briguori C, Cianflone D, Cosgrave J, Stankovic G, Godino C, Carlino M, Chieffo A, Montorfano M, Mussardo M, Michev I, Colombo A, Maseri A. Frequency of slow coronary flow following successful stent implantation and effect of Nitroprusside. Am J Cardiol. 2007 Apr 1;99(7):916-20. doi: 10.1016/j.amjcard.2006.10.057. Epub 2007 Feb 12.
Results Reference
background
PubMed Identifier
26905054
Citation
Wijnbergen I, van 't Veer M, Lammers J, Ubachs J, Pijls NH. Absolute coronary blood flow measurement and microvascular resistance in ST-elevation myocardial infarction in the acute and subacute phase. Cardiovasc Revasc Med. 2016 Mar;17(2):81-7. doi: 10.1016/j.carrev.2015.12.013. Epub 2016 Jan 7.
Results Reference
background
PubMed Identifier
27542781
Citation
van 't Veer M, Adjedj J, Wijnbergen I, Toth GG, Rutten MC, Barbato E, van Nunen LX, Pijls NH, De Bruyne B. Novel monorail infusion catheter for volumetric coronary blood flow measurement in humans: in vitro validation. EuroIntervention. 2016 Aug 20;12(6):701-7. doi: 10.4244/EIJV12I6A114.
Results Reference
background
PubMed Identifier
15226226
Citation
Gibson CM, Schomig A. Coronary and myocardial angiography: angiographic assessment of both epicardial and myocardial perfusion. Circulation. 2004 Jun 29;109(25):3096-105. doi: 10.1161/01.CIR.0000134278.50359.CB. No abstract available.
Results Reference
background

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Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia

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