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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>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<br>* Patients included in the study will undergo subsequently at 1-month after STEMI Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment<br>|

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 | 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 | 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 | 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 | 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 | QFR value at the index procedure in comparison with FFR value | within one month after ST-elevation myocardial infarction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dynamic 99mTc-Tetrofosmin CZT-SPECT, Myocardial perfusion imaging, fractional flow reserve, ST-elevation myocardial infarction