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
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Condition or disease | Intervention/treatment | Phase |
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Myocardial Infarction | Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT | Not Applicable |
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 |
Arm | Intervention/treatment |
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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
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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 |
- 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
- 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
- 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)
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Contact: JAMET Bastien | (0)240165521 ext +33 | Bastien.JAMET@chu-nantes.fr |
France | |
Nantes University Hospital | Recruiting |
Nantes, France, 44093 | |
Contact: Bastien JAMET, Dr 0240165521 ext +33 | |
Principal Investigator: Robin LE RUZ, dr |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial perfusion imaging fractional flow reserve ST-elevation myocardial infarction |
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 |