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. (Dyna-MI)

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Dynamic 99mTc-Tetrofosmin CZT-SPECT

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm study; 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	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: acute coronary syndrome; fractional flow reserve; Myocardial perfusion imaging; Dynamic 99mTc-Tetrofosmin CZT-SPECT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium tc-99m tetrofosmin
• Other Study ID Numbers: RC22_0698

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No