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NCT Number: NCT05940285

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.

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 .

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Key information

Conditions

Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic 99mTc-Tetrofosmin CZT-SPECT

Diagnostic Test

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

Primary outcomes

  1. Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR

    Time frame: within one month after ST-elevation myocardial infarction

    To determine MFR diagnostic performances in comparison with FFR

Secondary outcomes

  1. best MFR cut-off value

    Time frame: within one month after ST-elevation myocardial infarction

    To determine the best MFR cut-off value correlated with FFR value < 0.8

  2. MFR value correlated with IMR

    Time frame: within one month after ST-elevation myocardial infarction

    analysis of discrepancies between MFR value correlated with IMR (if low MFR value and normal FFR value)

  3. Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI

    Time frame: within one month after ST-elevation myocardial infarction

    To determine MFR diagnostic performances in comparison with conventional static MPI

  4. Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value

    Time frame: within one month after ST-elevation myocardial infarction

    QFR value at the index procedure in comparison with FFR value

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: Dyna-MI

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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