Clinical trial NCT05940285: Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison with Fractional Flow Reserve in Patients After Acute Coronary Syndrome
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 Acute Coronary Syndrome : Dyna-MI Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Dynamic 99mTc-Tetrofosmin CZT-SPECT
Myocardial perfusion imaging
fractional flow reserve
acute coronary syndrome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 acute coronary syndrome .


Eligibility criteria: Inclusion Criteria:

* Adult patient.
* Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis \&gt;= 50%) diagnosis during

  * primary percutaneous coronary intervention \&lt; 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 outcomes:
measure: Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
timeFrame: within one month after ST-elevation myocardial infarction
Secondary outcomes:
measure: best MFR cut-off value
timeFrame: within one month after ST-elevation myocardial infarction
measure: MFR value correlated with IMR
timeFrame: within one month after ST-elevation myocardial infarction
measure: Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI
timeFrame: within one month after ST-elevation myocardial infarction
measure: Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value
timeFrame: within one month after ST-elevation myocardial infarction
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: