Coronary Flow and Myocardial Viability: the FloVITA Study

Recruiting

• Conditions: Myocardial Ischemia; Myocardial Infarction
• Interventions: Device: Absolute coronary flow measurement; Device: Microvascular resistance measurement; Other: Cardiac MRI

• Registration Number: NCT04818918
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Study Start: 2021-05-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Inclusion criteria for the STEMI group:

  • ST segment elevation MI ≥7 days treated by angioplasty of the left anterior descending (LAD) artery
  • Scheduled to undergo angiography for fractional flow reserve (FFR) assessment of a lesion other than the infarct-related artery.

• Inclusion criteria for the control group:

  • patients undergoing non-urgent coronary angiography for stable angina or silent ischemia
  • with measure of the FFR on one or more vessels (intermediate lesion <90% without proven 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 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 in the 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 the national registry of research volunteers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI group	Absolute coronary flow measurement	Patients with anterior ST segment MI treated with percutaneous coronary intervention of the left anterior descending artery, at least 7 days prior to inclusion, and scheduled for new angiography to evaluate FFR of a lesion other than the infarct-related artery. Absolute coronary flow and microvascular resistance will be measured in the LAD.
STEMI group	Microvascular resistance measurement	Patients with anterior ST segment MI treated with percutaneous coronary intervention of the left anterior descending artery, at least 7 days prior to inclusion, and scheduled for new angiography to evaluate FFR of a lesion other than the infarct-related artery. Absolute coronary flow and microvascular resistance will be measured in the LAD.
STEMI group	Cardiac MRI	Patients with anterior ST segment MI treated with percutaneous coronary intervention of the left anterior descending artery, at least 7 days prior to inclusion, and scheduled for new angiography to evaluate FFR of a lesion other than the infarct-related artery. Absolute coronary flow and microvascular resistance will be measured in the LAD.
Control group	Microvascular resistance measurement	Patients undergoing non-urgent coronary angiography for stable angina or silent ischemia, with measure of FFR on one or more vessels (intermediate lesions \<90% without proven ischemia). Absence of any signfiicant lesion on the left anterior descending artery (as evaluated by angiography or FFR value \>0.8). Absolute coronary flow and microvascular resistance will be measured in the LAD.
Control group	Absolute coronary flow measurement	Patients undergoing non-urgent coronary angiography for stable angina or silent ischemia, with measure of FFR on one or more vessels (intermediate lesions \<90% without proven ischemia). Absence of any signfiicant lesion on the left anterior descending artery (as evaluated by angiography or FFR value \>0.8). Absolute coronary flow and microvascular resistance will be measured in the LAD.

Primary Outcome Measures

Name	Time	Method
Coronary flow (mL/min) in the LAD	At the end of the angiography procedure	Measurement of coronary flow in mL/min in the left anterior descending artery

Secondary Outcome Measures

Name	Time	Method
Myocardial necrosis	Cardiac MRI to be performed 7 to 30 days after index angiography procedure	Extent of myocardial necrosis on cardiac MRI (number of segments)
Microvascular resistance	At the end of the angiography procedure	Measurement of microvascular resistance in the LAD

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besancon, France