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Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

NCT04542889 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

  • STEMI - ST Elevation Myocardial Infarction

Interventions

DIAGNOSTIC_TEST

Absolute coronary flow and resistance measurements

Thermodilution-based measurements of absolute coronary resistances using the FFR pressure guide (PressureWire® Certus® from St Jude Medical Abbott) and the Rayflow® microcatheter (Hexacath, Paris, France).

DIAGNOSTIC_TEST

IMR measurement

IMR measurement by thermodilution using the St Jude pressure guide.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Georgios SIDERIS, MD · APHP, Lariboisière Hospital, Cardiology Department

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-06-26
Completion
2021-06-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542889 on ClinicalTrials.gov