FloVita: Coronary Flow and Myocardial Viability: the FloVITA Study

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04818918

Collaborator

(none)

Enrollment

Location

13.4

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Myocardial Ischemia	Device: Absolute coronary flow measurement Device: Microvascular resistance measurement Other: Cardiac MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study

Actual Study Start Date :

May 19, 2021

Anticipated Primary Completion Date :

May 20, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
STEMI group 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.	Device: Absolute coronary flow measurement Absolute coronary flow will be measured. Device: Microvascular resistance measurement Microvascular resistance will be measured. Other: Cardiac MRI Cardiac MRI will be performed to evaluate myocardial viability.
Control group 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.	Device: Absolute coronary flow measurement Absolute coronary flow will be measured. Device: Microvascular resistance measurement Microvascular resistance will be measured.

Arm

Intervention/Treatment

STEMI group

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.

Device: Absolute coronary flow measurement

Absolute coronary flow will be measured.

Device: Microvascular resistance measurement

Microvascular resistance will be measured.

Other: Cardiac MRI

Cardiac MRI will be performed to evaluate myocardial viability.

Control group

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.

Device: Absolute coronary flow measurement

Absolute coronary flow will be measured.

Device: Microvascular resistance measurement

Microvascular resistance will be measured.

Outcome Measures

Primary Outcome Measures

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

Microvascular resistance [At the end of the angiography procedure]
Measurement of microvascular resistance in the LAD
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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