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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT

• Registration Number: NCT05940285
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Study Start: 2023-10-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07
• Primary Completion: 2025-11-20
• Study Completion: 2026-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Dynamic 99mTc-Tetrofosmin CZT-SPECT	Patients included in the study will undergo subsequently at 1-month after acute coronary syndrome Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France