ST Elevation (STEMI) Myocardial Infarction of Other SitesPREGICANCT01113268
PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure
A study testing Cohort in people with ST Elevation (STEMI) Myocardial Infarction of Other Sites, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction of Other Sites
- What is being tested?
- Cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2010to 23 Aug 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Selection criteria
- Any patient hospitalised in the CCU of the participating centers:
- with a diagnosis of a first MI
- with ST segment elevation and/or Q wave at admission
- with troponin elevation
- seen within the first 24 hours after symptom onset
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- aged between 18 and 80 years is selected.
- consent emergency clause: His/her informed consent is obtained and he/she signs the consent form or However, if a member of the patients' family is present, his/her consent must be obtained or no consent
- The first transthoracic echocardiography is performed at day 4±2 in all patients selected.
- In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included.
Who cannot join
- Non-selection criteria:
- Informed consent not obtained.
- Patients with diagnosis of previous MI, hypertrophic or dilated cardiomyopathy, significant valvular heart disease, chronic atrial fibrillation, or pace maker or any permanently implanted device susceptible to interfere with LV remodelling.
- Patients with preexisting heart failure.
- Patients having undergone previous cardiac surgery.
- Patients having received chemotherapy susceptible to induce LV remodeling (anthracyclines).
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- Patients with an associated short-time life-threatening disease.
- Patients with poor echogenicity.
- Patients without health insurance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Candidate Genes/Signalling Pathways in the Progression Towards Heart Failure: Study in a Cohort of Patients With a First Myocardial Infarction (PREGICA Patient Collection : Genetic Predisposition to Heart Failure)
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Our main hypothesis is that there is, for a given initial biomechanical stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in the individual susceptibility to develop left ventricular remodelling and to progress towards heart failure, and that this variation is linked to genetic variants between individuals.
Read the detailed description
The research program comprises 4 phases: a selection phase at D0-D1, a pre-inclusion and an inclusion phase at D4±2, a visit at M6, and a 5 year follow up phase.
Visit at Day 0 - Day 1:
- The first 12-lead ECG, to be included in the observation book, is performed.
- The first blood sample is taken.
Visit at Day 4±2:
- The first transthoracic echocardiography is performed in all patients selected.
- In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included.
- Demographic data, medical and surgical anteriority, detailed circumstances of occurrence of the MI and any other relevant information is obtained during an interview.
- The second 12-lead ECG is performed.
- The second blood sample is taken.
- The first MRI is performed (optional)
Visit at 6 months:
- The second transthoracic echocardiography is performed.
- The third 12-lead ECG is performed.
- The third blood sample is taken.
- A 24-hour Holter-ECG monitoring is performed (optional)
- The second MRI is performed (optional)
Five year follow up (phone contact until 7 years after inclusion):
Each patient included at day 4±2 will be contacted by phone 1, 2, 3, 4 and 5 years post-MI to obtain information regarding cardiovascular events and hospitalizations. If the patient cannot be contacted directly, we will try to contact a member of his/her family or his/her family physician.
- Being tested
- Cohort
- Keywords
- Patient collection, Cardiac remodelling, Echography, Magnetic Resonance Imaging, Gene polymorphisms, Biomarkers
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortOther
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach.
| Study group | Role | What they receive |
|---|---|---|
| 1:cohort | Other | Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Receives: Other: Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of patients with LV remodeling from those without remodelling
Our main judgement criterion allowing to distinguish patients with LV remodeling from those without remodelling will be an increase in LV end-diastolic volume > 20% between day 4±2 and month 6 post-MI.
Measured: at day 4±2, at month 6
Secondary outcomes (2)
Degree of LV remodelling
To evaluate the degree of LV remodelling (including ventricular arrhythmias) 6 months after a first ST-segment elevation myocardial infarction (STEMI) or Q-wave MI at the era of early revascularization.
Measured: at month 6
Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events
To evaluate the power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias, death) in a 5-year patient follow-up (years 3 to 7).
Measured: years 3 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study start30 Sep 2010
- Primary completion30 Sep 2017
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial Infarction of Other SitesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien LOGEART, MD,PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113268
- Sponsor's protocol ID
- P081116
- Other IDs
- 2010-A00156-33
- Acronym
- PREGICA
- Status last verified
- Jun 2022
- First submitted
- 28 Apr 2010
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Masurkar N, Bouvet M, Logeart D, Jouve C, Drame F, Claude O, Roux M, Delacroix C, Bergerot D, Mercadier JJ, Sirol M, Gellen B, Livrozet M, Fayol A, Robidel E, Tregouet DA, Marazzi G, Sassoon D, Valente M, Hulot JS. Novel Cardiokine GDF3 Predicts Adverse Fibrotic Remodeling After Myocardial Infarction. Circulation. 2023 Feb 7;147(6):498-511. doi: 10.1161/CIRCULATIONAHA.121.056272. Epub 2022 Dec 9.
PubMed 36484260
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Candidate Genes/Signalling Pathways in the Progression Towards Heart Failure: Study in a Cohort of Patients With a First Myocardial Infarction (PREGICA Patient Collection : Genetic Predisposition to Heart Failure)
- ClinicalTrials.gov ID
- NCT01113268
- Acronym / sponsor ID
- PREGICA / P081116
- Keywords
- Patient collection, Cardiac remodelling, Echography, Magnetic Resonance Imaging, Gene polymorphisms, Biomarkers
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 29 Apr 2010 (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.
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Our main hypothesis is that there is, for a given initial biomechanical stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in the individual susceptibility to develop left ventricular remodelling and to progress towards heart failure, and that this variation is linked to genetic variants between individuals.
Detailed description
The research program comprises 4 phases: a selection phase at D0-D1, a pre-inclusion and an inclusion phase at D4±2, a visit at M6, and a 5 year follow up phase.
Visit at Day 0 - Day 1:
- The first 12-lead ECG, to be included in the observation book, is performed.
- The first blood sample is taken.
Visit at Day 4±2:
- The first transthoracic echocardiography is performed in all patients selected.
- In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included.
- Demographic data, medical and surgical anteriority, detailed circumstances of occurrence of the MI and any other relevant information is obtained during an interview.
- The second 12-lead ECG is performed.
- The second blood sample is taken.
- The first MRI is performed (optional)
Visit at 6 months:
- The second transthoracic echocardiography is performed.
- The third 12-lead ECG is performed.
- The third blood sample is taken.
- A 24-hour Holter-ECG monitoring is performed (optional)
- The second MRI is performed (optional)
Five year follow up (phone contact until 7 years after inclusion):
Each patient included at day 4±2 will be contacted by phone 1, 2, 3, 4 and 5 years post-MI to obtain information regarding cardiovascular events and hospitalizations. If the patient cannot be contacted directly, we will try to contact a member of his/her family or his/her family physician.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1:cohort | Other | Other: CohortOur main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Selection criteria
- with a diagnosis of a first MI
- with ST segment elevation and/or Q wave at admission
- with troponin elevation
- seen within the first 24 hours after symptom onset
Key exclusion criteria (9 listed)
- Informed consent not obtained.
- Patients with diagnosis of previous MI, hypertrophic or dilated cardiomyopathy, significant valvular heart disease, chronic atrial fibrillation, or pace maker or any permanently implanted device susceptible to interfere with LV remodelling.
- Patients with preexisting heart failure.
- Patients having undergone previous cardiac surgery.
- Patients having received chemotherapy susceptible to induce LV remodeling (anthracyclines).
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 |
|---|---|---|
| CohortOur main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. | Other | 1:cohort |
Primary outcome
Identification of patients with LV remodeling from those without remodelling
Time frame: at day 4±2, at month 6
Our main judgement criterion allowing to distinguish patients with LV remodeling from those without remodelling will be an increase in LV end-diastolic volume > 20% between day 4±2 and month 6 post-MI.
2 secondary outcomes
Degree of LV remodelling
Time frame: at month 6
Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events
Time frame: years 3 to 7
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 36484260Masurkar N, Bouvet M, Logeart D, Jouve C, Drame F, Claude O, Roux M, Delacroix C, Bergerot D, Mercadier JJ, Sirol M, Gellen B, Livrozet M, Fayol A, Robidel E, Tregouet DA, Marazzi G, Sassoon D, Valente M, Hulot JS. Novel Cardiokine GDF3 Predicts Adverse Fibrotic Remodeling After Myocardial Infarction. Circulation. 2023 Feb 7;147(6):498-511. doi: 10.1161/CIRCULATIONAHA.121.056272. Epub 2022 Dec 9.
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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.
Damien LOGEART, MD,PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohort in people with ST Elevation (STEMI) Myocardial Infarction of Other Sites, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 9 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 25 Aug 2023. 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. 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?
Identification of patients with LV remodeling from those without remodelling (time frame: at day 4±2, at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113268, which also lists 1 linked publication.
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 25 Aug 2023.