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
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

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