Coronary Flow and Myocardial Viability: the FloVITA Study (FloVita)

January 31, 2024 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with recent (>=7 days) ST segment elevation MI for the intervention group, and patients with stable angina or silent ischemia for the control group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow (mL/min) in the LAD
Time Frame: At the end of the angiography procedure
Measurement of coronary flow in mL/min in the left anterior descending artery
At the end of the angiography procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Nicolas Meneveau, MD, PhD, Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

August 20, 2024

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0123456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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