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

Study Overview
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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.

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.

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

Conditions
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Coronary Microvascular Disease, Myocardial Infarction

Intervention / Treatment
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* Drug: Drug-mediated hyperemia
* Other: Flow-mediated hyperemia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 minutes | 
| 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). | 2 minutes | 
| 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. | 2 minutes | 
| 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. | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Microvascular Disease, Myocardial Infarction