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Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison With Fractional Flow Reserve in Patients After ST-elevation Myocardial Infarction (Dyna-MI)

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ClinicalTrials.gov Identifier: NCT05940285
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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 ST-elevation myocardial infarction.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : October 20, 2023
Estimated Primary Completion Date : November 20, 2025
Estimated Study Completion Date : October 20, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm study
Patients included in the study will undergo subsequently at 1-month after STEMI (ST-elevation Myocardial Infartion) 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 STEMI Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05940285


Contacts
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Contact: JAMET Bastien (0)240165521 ext +33 Bastien.JAMET@chu-nantes.fr

Locations
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France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Bastien JAMET, Dr    0240165521 ext +33      
Principal Investigator: Robin LE RUZ, dr         
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT05940285    
Other Study ID Numbers: RC22_0698
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Dynamic 99mTc-Tetrofosmin CZT-SPECT
Myocardial perfusion imaging
fractional flow reserve
ST-elevation myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Technetium tc-99m tetrofosmin
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action