TerminatedNot Applicable

Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

Stopped: Departure of principal investigator

France31 participantsStarted 2020-09-07

Plain-language summary

In the management of acute myocardial infarction treated with primary angioplasty, despite effective epicardial clearance obtained in 95% of cases, microvascular obstruction (MVO) in the damaged territory concerns 50% of patients. The Index of Microvascular Resistance (IMR) allows early assessment of the microcirculatory state during the angioplasty procedure. A value of IMR\>40 indicates MVO and is correlated with morbi-mortality. A new method for immediate evaluation of MVO using thermodilution with a new Rayflow® microcatheter has been described: it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow. We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty, comparing to IMR. The main objective is to study the diagnostic performance of Rayflow® to predict MVO - no reflow (NR) - in ST-Elevation Myocardial Infarction (STEMI) patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO. The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other, not indexed and indexed to the myocardial mass at risk (coronary resistance, IMR, CFR, Resistance Reserve Ratio) and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1, D2 and D3.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acute ST + coronary syndrome seen within 12 hours after the initial pain: ST offset in 2 contiguous leads ≥ 1mm or ≥ 2mm in precordial or inaugural left branch block, permanent or transient with chest pain \> 20 min * Patient with an indication for emergency coronary angiography with angioplasty * Acute occlusion of a large caliber artery corresponding to an APPROACH score ≥21: proximal or mean anterior interventricular artery, proximal circumflex artery or proximal right coronary artery * Final Thrombolysis In Myocardial Infarction (TIMI) of 2 or 3 at the end of the angioplasty procedure regardless of the initial TIMI score * Free and informed written consent to participate in the study Exclusion Criteria: * Known history of infarction in the same territory : STEMI or NSTEMI (angioplasty programmed for angina does not constitute a criterion for non-inclusion) * Haemodynamic instability requiring the initial use of vasopressive amines or circulatory assistance (counterpulse balloon or extracorporeal membrane oxygenation) or mechanical ventilation (a recovered cardiopulmonary arrest does not constitute an exclusion criterion) * Technical impossibility of performing IMR or Rayflow® measurements (tortuous or calcified artery) * Persistent high-grade atrioventricular block after primary angioplasty * Cardiomyopathy or severe valvulopathy which can induce microcirculatory abnormalities (congenital heart diseases, dilated cardiomyopathy, cardiac amyloidosis…

What they're measuring

Absolute coronary resistance

Timeframe: Immediately after angioplasty

Microvascular obstruction on MRI

Timeframe: Day 7

Trial details

NCT IDNCT04542889

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-26