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NCT05940285 Clinical Trial

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

Myocardial Infarction Clinical Trial

— Dyna-MI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05940285
Other study ID # RC22_0698
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date October 20, 2026

Study information
Verified date November 2023
Source Nantes University Hospital
Contact JAMET Bastien
Phone (0)240165521
Email Bastien.JAMET@chu-nantes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 20, 2026
Est. primary completion date November 20, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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