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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Microvascular Disease Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Drug-mediated hyperemia

Intervention Type 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

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

Group Type EXPERIMENTAL

Flow-mediated hyperemia

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Flow-mediated hyperemia

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No