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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)

Primary Purpose

Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic 99mTc-Tetrofosmin CZT-SPECT
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Dynamic 99mTc-Tetrofosmin CZT-SPECT, Myocardial perfusion imaging, fractional flow reserve, ST-elevation myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
To determine MFR diagnostic performances in comparison with FFR

Secondary Outcome Measures

best MFR cut-off value
To determine the best MFR cut-off value correlated with FFR value < 0.8
MFR value correlated with IMR
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
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
QFR value at the index procedure in comparison with FFR value

Full Information

First Posted
July 3, 2023
Last Updated
July 3, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05940285
Brief Title
Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison With Fractional Flow Reserve in Patients After ST-elevation Myocardial Infarction
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Dynamic 99mTc-Tetrofosmin CZT-SPECT, Myocardial perfusion imaging, fractional flow reserve, ST-elevation myocardial infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic 99mTc-Tetrofosmin CZT-SPECT
Intervention Description
Patients included in the study will undergo subsequently at 1-month after STEMI Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment
Primary Outcome Measure Information:
Title
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
Description
To determine MFR diagnostic performances in comparison with FFR
Time Frame
within one month after ST-elevation myocardial infarction
Secondary Outcome Measure Information:
Title
best MFR cut-off value
Description
To determine the best MFR cut-off value correlated with FFR value < 0.8
Time Frame
within one month after ST-elevation myocardial infarction
Title
MFR value correlated with IMR
Description
analysis of discrepancies between MFR value correlated with IMR (if low MFR value and normal FFR value)
Time Frame
within one month after ST-elevation myocardial infarction
Title
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI
Description
To determine MFR diagnostic performances in comparison with conventional static MPI
Time Frame
within one month after ST-elevation myocardial infarction
Title
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value
Description
QFR value at the index procedure in comparison with FFR value
Time Frame
within one month after ST-elevation myocardial infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JAMET Bastien
Phone
(0)240165521
Ext
+33
Email
Bastien.JAMET@chu-nantes.fr
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bastien JAMET, Dr
Phone
0240165521
Ext
+33
First Name & Middle Initial & Last Name & Degree
Robin LE RUZ, dr

12. IPD Sharing Statement

Learn more about this trial

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

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