Coronary Flow and Myocardial Viability: the FloVITA Study

Last updated: January 31, 2024
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Circulation Disorders

Chest Pain

Treatment

Cardiac MRI

Microvascular resistance measurement

Absolute coronary flow measurement

Clinical Study ID

NCT04818918
2020-0123456
  • Ages 18-80
  • All Genders

Study Summary

Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be severe by angiography may cause limited ischemia (with an FFR value >0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass.

Therefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI.

In a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria for the STEMI group:
  • ST segment elevation MI ≥7 days treated by angioplasty of the left anteriordescending (LAD) artery
  • Scheduled to undergo angiography for fractional flow reserve (FFR) assessment ofa lesion other than the infarct-related artery.
  • Inclusion criteria for the control group:
  • patients undergoing non-urgent coronary angiography for stable angina or silentischemia
  • with measure of the FFR on one or more vessels (intermediate lesion <90% withoutproven ischemia)
  • absence of any significant lesion on the LAD (as assessed by angiography or FFR>0.8)
  • Inclusion criteria for both groups:
  • Written informed consent
  • Affiliation to a social security regimen (or beneficiary thereof).

Exclusion

Exclusion Criteria:

  • Target vessel (LAD) not permeable.
  • FFR <0.8 in the LAD
  • Coronary spasm
  • Left ventricular ejection fraction <0.50 or a history of anterior MI in patients inthe control group
  • Hypertrophic cardiomyopathy
  • Severe valvular heart disease
  • History of coronary artery bypass graft
  • Patients with limited legal capacity or patients under guardianship/tutorship
  • Patients with anticipated poor compliance as assessed by the investigator
  • Patients not affiliated to any social security regime.
  • Pregnant women.
  • Subjects within the exclusion period of another clinical trial as noted in thenational registry of research volunteers

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Cardiac MRI
Phase:
Study Start date:
May 19, 2021
Estimated Completion Date:
August 20, 2024

Connect with a study center

  • CHU Besancon

    Besancon, 25000
    France

    Active - Recruiting

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