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Active, not recruiting Not applicable

Evaluation of the Diagnostic Performance of Dynamic Myocardial Perfusion Scintigraphy in Comparison With Invasive Intracoronary FFR Measurement, in the Assessment of Significant Residual Coronary Stenosis After Acute Coronary Syndrome: Dyna-MI Pilot Study.

NCT05940285 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-20
Last updated
2026-04-08

Condition(s) studied

Myocardial Infarction

Investigational drug(s) / intervention(s)

Dynamic 99mTc-Tetrofosmin CZT-SPECT

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

Study 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 acute coronary syndrome .

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 opercutaneous revascularisation of the culprit lesion within 24 to 48 hours of an acute non-ST-segment elevation coronary syndrome. * 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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Nantes University Hospital Nantes France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05940285 on ClinicalTrials.gov ↗ ← All trials in France