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

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05940285

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR [within one month after ST-elevation myocardial infarction]
To determine MFR diagnostic performances in comparison with FFR

Secondary Outcome Measures

best MFR cut-off value [within one month after ST-elevation myocardial infarction]
To determine the best MFR cut-off value correlated with FFR value < 0.8
MFR value correlated with IMR [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)
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI [within one month after ST-elevation myocardial infarction]
To determine MFR diagnostic performances in comparison with conventional static MPI
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value [within one month after ST-elevation myocardial infarction]
QFR value at the index procedure in comparison with FFR value

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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