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Completed

NCT Number: NCT04685941

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

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.

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Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Infarction Ischemia Microvascular Angina Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug-mediated hyperemia

Drug

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.

Flow-mediated hyperemia

Other

Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.

Primary outcomes

  1. 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. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Collaborators

  • Barcicore-Lab

Registry information

Acronym: RAIN FLOW

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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