Myocardial InfarctionDyna-MINCT05940285
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.
A study testing Dynamic 99mTc-Tetrofosmin CZT-SPECT in people with Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Dynamic 99mTc-Tetrofosmin CZT-SPECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non adult patient.
- Adult patient under tutelage.
- Reproductive age women.
- Medical history of myocardial infarction or coronary artery bypass surgery.
- Cardiogenic shock.
- Cardiomyopathy.
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- Regadenoson/adenosine/FFR contraindication.
- 99mTc-Tetrofosmin hypersensibility.
- Small non-culprit coronary arteries.
- Participation to another interventional study.
Trial locations and contacts
1 site in 1 country.
About this 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 .
- Conditions
- Myocardial Infarction
- Being tested
- Dynamic 99mTc-Tetrofosmin CZT-SPECT
- Keywords
- Dynamic 99mTc-Tetrofosmin CZT-SPECT, Myocardial perfusion imaging, fractional flow reserve, acute coronary syndrome
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic 99mTc-Tetrofosmin CZT-SPECTDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | 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 Receives: Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
To determine MFR diagnostic performances in comparison with FFR
Measured: within one month after ST-elevation myocardial infarction
Secondary outcomes (4)
best MFR cut-off value
To determine the best MFR cut-off value correlated with FFR value < 0.8
Measured: 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)
Measured: 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
Measured: 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
Measured: within one month after ST-elevation myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start20 Oct 2023
- Primary completion20 May 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940285
- Sponsor's protocol ID
- RC22_0698
- Acronym
- Dyna-MI
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05940285
- Acronym / sponsor ID
- Dyna-MI / RC22_0698
- Conditions
- Myocardial Infarction
- Keywords
- Dynamic 99mTc-Tetrofosmin CZT-SPECT, Myocardial perfusion imaging, fractional flow reserve, acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Diagnostic Test: Dynamic 99mTc-Tetrofosmin CZT-SPECTPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient.
- Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis \>= 50%) diagnosis during
- Written consent.
- Social security affiliation
Key exclusion criteria (10 listed)
- Non adult patient.
- Adult patient under tutelage.
- Reproductive age women.
- Medical history of myocardial infarction or coronary artery bypass surgery.
- Cardiogenic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic 99mTc-Tetrofosmin CZT-SPECTPatients 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 | Single arm study |
Primary outcome
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
4 secondary outcomes
best MFR cut-off value
Time frame: within one month after ST-elevation myocardial infarction
MFR value correlated with IMR
Time frame: 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
Time frame: within one month after ST-elevation myocardial infarction
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic 99mTc-Tetrofosmin CZT-SPECT in people with Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.