Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison With Fractional Flow Reserve in Patients After ST-elevation Myocardial Infarction (Dyna-MI)

November 2, 2023 updated by: Nantes University Hospital

Diagnostic Performances Assessment of Dynamic 99mTc- Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison With Invasive Intra-coronary Fractional Flow Reserve Measurement in Patients With Significant Residual Coronary Artery Stenosis After ST-elevation Myocardial Infarction : Dyna-MI Pilot Study.

Dynamic 99mTc-Tetrofosmin CZT-SPECT myocardial perfusion imaging (MPI) is an advanced functional imaging technique giving important myocardial flow quantification added data in comparison with conventional MPI, especially in coronary multi vessel disease. A large-scale validation of diagnostic performances of myocardial flow reserve (MFR) estimated with Dynamic 99mTc-Tetrofosmin CZT-SPECT MPI would allow a non-invasive approach instead of invasive intra-coronary fractional flow reserve (FFR) measurement. The aim of this prospective study is to assess diagnostic performances of MFR calculated with dynamic 99mTc-Tetrofosmin CZT-SPECT MPI in comparison with invasive intra-coronary FFR measurement in patients with significant residual coronary arteries stenosis after ST-elevation myocardial infarction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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

  • France
      • Nantes, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Contact:
          • Bastien JAMET, Dr
          • Phone Number: +33 0240165521
        • Principal Investigator:
          • Robin LE RUZ, dr

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient.
  • Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis >= 50%) diagnosis during primary percutaneous coronary intervention < 12h after ST-elevation myocardial infarction.
  • Written consent.
  • Social security affiliation

Exclusion Criteria:

  • Non adult patient.
  • Adult patient under tutelage.
  • Reproductive age women.
  • Medical history of myocardial infarction or coronary artery bypass surgery.
  • Cardiogenic shock.
  • Cardiomyopathy.
  • Regadenoson/adenosine/FFR contraindication.
  • 99mTc-Tetrofosmin hypersensibility.
  • Small non-culprit coronary arteries.
  • Participation to another interventional study.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study
Patients included in the study will undergo subsequently at 1-month after STEMI (ST-elevation Myocardial Infartion) Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment
Diagnostic test: Dynamic 99mTc-Tetrofosmin CZT-SPECT
Patients included in the study will undergo subsequently at 1-month after STEMI Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
Time Frame: within one month after ST-elevation myocardial infarction
To determine MFR diagnostic performances in comparison with FFR
within one month after ST-elevation myocardial infarction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best MFR cut-off value
Time Frame: within one month after ST-elevation myocardial infarction
To determine the best MFR cut-off value correlated with FFR value < 0.8
within one month after ST-elevation myocardial infarction
MFR value correlated with IMR
Time Frame: within one month after ST-elevation myocardial infarction
analysis of discrepancies between MFR value correlated with IMR (if low MFR value and normal FFR value)
within one month after ST-elevation myocardial infarction
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI
Time Frame: within one month after ST-elevation myocardial infarction
To determine MFR diagnostic performances in comparison with conventional static MPI
within one month after ST-elevation myocardial infarction
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value
Time Frame: within one month after ST-elevation myocardial infarction
QFR value at the index procedure in comparison with FFR value
within one month after ST-elevation myocardial infarction

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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)

October 20, 2023

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

October 20, 2026

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0698

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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