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

Fundación EPIC

Status: Completed

Conditions: Coronary Microvascular Disease; Myocardial Infarction

Treatments: Drug: Drug-mediated hyperemia; Other: Flow-mediated hyperemia

Study type: Interventional

Funder types: Other

Identifiers

NCT04685941

EPIC24-RAIN-FLOW

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Drug-mediated hyperemia

Other group

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

Treatment:

Drug: Drug-mediated hyperemia

Flow-mediated hyperemia

Experimental group

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

Treatment:

Other: Flow-mediated hyperemia