ST Elevation Myocardial InfarctionREMOD-TEPNCT02789098
Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction
A study testing (15)-O water positron emission tomography and Biomarkers in people with ST Elevation Myocardial Infarction, run by University Hospital, Caen at 1 site in France.
Trial summary
Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- (15)-O water positron emission tomography and Biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2016to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- First ST Elevation Myocardial Infarction
- Primary Percutaneous Coronary Intervention (TIMI 3)
- Single vessel coronary artery disease
- Age over 18 years
- Informed Consent dated and signed
- Written and spoken French
- Beneficiary of social security insurance
Who cannot join
- No Primary Percutaneous Coronary Intervention
- TIMI 0-2 after Primary Percutaneous Coronary Intervention
- Significant two or three-vessel coronary artery disease (> 70% stenosis in at least one of the other two coronary arteries)
- Past history of myocardial infarction before STEMI
- Mechanical complication (ischaemic mitral regurgitation, interventricular septal defect, cardiac tamponade) or clinical signs of heart failure
- Pregnant and / or lactating
- Age under 18 years or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling
Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- (15)-O water positron emission tomography and Biomarkers
- Keywords
- ST Elevation Myocardial Infarction, Ventricular remodeling, Biomarkers, Coronary endothelial function, Positron Emission Tomography
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(15)-O water positron emission tomography and BiomarkersOther
Coronary endothelial function is assessed using (15)-O water positron emission tomography and cold pressor test . The response to the test is defined by the percentage increase myocardial blood flow . Assessment of fibrosis, inflammation an endothelial function is performed using biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Other | All patients included in this study (1 arm) Receives: Other: (15)-O water positron emission tomography and Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of coronary endothelial function
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
Measured: 3 months
Measurement of fibrosis
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
Measured: 3 months
Secondary outcomes (1)
Correlating biomarkers with local and global parameters of coronary endothelial function , inflammation and myocardial fibrosis with early echocardiographic parameters of left ventricular remodeling and cardiac magnetic resonance imaging
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start13 Oct 2016
- Primary completion29 Oct 2024
- Study completion30 Sep 2025
Why it stopped: lack of patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Farzin GF BEYGUI, PhD, Study chair, University Hospital, CaenAlain MA Manrique, PhD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789098
- Sponsor's protocol ID
- 2015-A01650-49
- Acronym
- REMOD-TEP
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling
- ClinicalTrials.gov ID
- NCT02789098
- Acronym / sponsor ID
- REMOD-TEP / 2015-A01650-49
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST Elevation Myocardial Infarction, Ventricular remodeling, Biomarkers, Coronary endothelial function, Positron Emission Tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Société Française de Cardiologie
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | Other | Other: (15)-O water positron emission tomography and BiomarkersAll patients included in this study (1 arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First ST Elevation Myocardial Infarction
- Primary Percutaneous Coronary Intervention (TIMI 3)
- Single vessel coronary artery disease
- Age over 18 years
- Informed Consent dated and signed
Key exclusion criteria (7 listed)
- No Primary Percutaneous Coronary Intervention
- TIMI 0-2 after Primary Percutaneous Coronary Intervention
- Significant two or three-vessel coronary artery disease (> 70% stenosis in at least one of the other two coronary arteries)
- Past history of myocardial infarction before STEMI
- Mechanical complication (ischaemic mitral regurgitation, interventricular septal defect, cardiac tamponade) or clinical signs of heart failure
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 |
|---|---|---|
| (15)-O water positron emission tomography and BiomarkersCoronary endothelial function is assessed using (15)-O water positron emission tomography and cold pressor test . The response to the test is defined by the percentage increase myocardial blood flow . Assessment of fibrosis, inflammation an endothelial function is performed using biomarkers. | Other | STEMI |
Primary outcome
Measurement of coronary endothelial function
Time frame: 3 months
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
Measurement of fibrosis
Time frame: 3 months
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
1 secondary outcome
Correlating biomarkers with local and global parameters of coronary endothelial function , inflammation and myocardial fibrosis with early echocardiographic parameters of left ventricular remodeling and cardiac magnetic resonance imaging
Time frame: 3 months
Results and safety
The study was stopped early (reason given: lack of patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Farzin GF BEYGUI, PhD study chair
University Hospital, Caen
Alain MA Manrique, PhD study chair
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (15)-O water positron emission tomography and Biomarkers in people with ST Elevation Myocardial Infarction, run by University Hospital, Caen 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jun 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?
The study was stopped early (reason given: lack of patient). Results are not available in the source record.
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?
Measurement of coronary endothelial function (time frame: 3 months). The study lists 2 primary outcomes in all. 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 18 Jun 2026.