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

November 9, 2022 updated by: Fundación EPIC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar
      • Madrid, Spain, 28006
        • Hospital La Princesa
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Drug-mediated hyperemia
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
Drug: Drug-mediated hyperemia
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.
Experimental: Flow-mediated hyperemia
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
Other: Flow-mediated hyperemia
Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic TIMI frame count
Time Frame: 2 minutes
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).
2 minutes
Minimal microcirculatory resistance (MMR)
Time Frame: 2 minutes
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).
2 minutes
Comparison of the MMR in the experimental group during the two-minutes saline infusion
Time Frame: 2 minutes
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.
2 minutes
Comparison of the Absolute coronary flow between the study groups.
Time Frame: 2 minutes
Absolute coronary flow is performed simultaneously with the MMR. This value shows the coronary blood flow of the culprit artery during maximal hyperemia.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Collaborators

Barcicore-Lab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC24-RAIN-FLOW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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