Myocardial InfarctionMAP-IDMNCT00859300
MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction
An observational study of Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
We propose a comparative case-control study on the 2 following groups of patients: Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct, Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct. 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?
- Blood sample
- How many people
- 1,011 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Jun 2015
- Phase
- Observational
- 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
Study population: Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct, Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.
Who may be able to join
- All patients admitted to ICU for MI and presenting the following criteria:
- Age > 18
- Group 1 (Case) Patients with cardiac arrest and ventricular fibrillation developed up to 24 h post MI Group 2 (control) Patients with MI (no ventricular fibrillation)
- Written informed consent.
Who cannot join
- No written informed consent
- Known Medical History of cardiomyopathy, including acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study
We propose a comparative case-control study on the 2 following groups of patients:
- Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
- Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.
Read more
The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.
The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.
This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.
Read the detailed description
The number of sudden death is estimated around 50000 in France. In most cases, these deaths are due to myocardial infarction. This complication occurs, for 70% of cases, at the patient's residence, within 30 minutes following the thoracic pain. Emergency care often comes too late and allows only 2% of the patients having a heart failure to be revitalized.
At equal sex, age and clinical status, patients may or not develop ventricular rhythm disorders. Then, the notions of risk background and genetic disposition should be investigated.
No prospective study has been conducted on a sufficient number of patients yet. Such a study and the recent development of new genetic technologies will help identifying markers of sudden death risk at the acute phase of myocardial infarction.
The study we are implementing will increase knowledge on sudden death mechanisms at the acute phase of myocardial infarction. The analysis of phenotypic/genotypic relations will lead to an identification of new risk markers. Further evaluations of new diagnostic and therapeutic strategies will be possible on the basis of this trial.
Ventricular fibrillation at the acute phase of myocardial infarction follows a polygenic determinism. The genes involved in this electrical trouble are those which lead to the expression of potassic, calcic and sodic channels of ventricular myocytes: KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2, PRKAG2, RyR2, PKP2, DSP, CASQ2, CACNA1C, and FKBP1B.
An association of a favourable genetic background and ischemia represents a cause for ventricular arrhythmia as a complication of myocardial infarction.
Haplotypes or genes considered as new markers for sudden death risk of ischemic origin will be searched.
- Conditions
- Myocardial Infarction
- Being tested
- Blood sample
- Keywords
- myocardial infarction, ventricular fibrillation, sudden death, polymorphism
- Medical subject headings
- Myocardial Infarction, Ventricular Fibrillation, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleGenetic
Blood sample Determination of genetic background
Blood sampleGenetic
Blood sample Determination of genetic background
| Study group | Role | What they receive |
|---|---|---|
| 1 | 500 patients with ventricular fibrillation at the acute phase of myocardial infarct Receives: Genetic: Blood sample | |
| 2 | 500 patients without ventricular fibrillation at the acute phase of myocardial infarct. Receives: Genetic: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.
Measured: Correlation phenotype/genotype
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEVALIER Philippe, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859300
- Sponsor's protocol ID
- 2007.463
- Acronym
- MAP-IDM
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2008
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chevalier P, Roy P, Bessiere F, Morel E, Ankou B, Morgan G, Halder I, London B, Minobe WA, Slavov D, Deliniere A, Bochaton T, Paganelli F, Lesavre N, Boiteux C, Mansourati J, Maury P, Clerici G, Winum PF, Huebler SP, Carroll IA, Bristow MR. Impact of Neuroeffector Adrenergic Receptor Polymorphisms on Incident Ventricular Fibrillation During Acute Myocardial Ischemia. J Am Heart Assoc. 2023 Mar 21;12(6):e025368. doi: 10.1161/JAHA.122.025368. Epub 2023 Mar 16.
PubMed 36926933Chevalier P, Moreau A, Bessiere F, Richard S, Chahine M, Millat G, Morel E, Paganelli F, Lesavre N, Placide L, Montestruc F, Ankou B, Puertas RD, Asatryan B, Deliniere A; MAP-IDM Investigators. Identification of Cx43 variants predisposing to ventricular fibrillation in the acute phase of ST-elevation myocardial infarction. Europace. 2023 Feb 8;25(1):101-111. doi: 10.1093/europace/euac128.
PubMed 35942675
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study
- ClinicalTrials.gov ID
- NCT00859300
- Acronym / sponsor ID
- MAP-IDM / 2007.463
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, ventricular fibrillation, sudden death, polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Mar 2009 (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.
We propose a comparative case-control study on the 2 following groups of patients:
- Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
- Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.
The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.
The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.
This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.
Detailed description
The number of sudden death is estimated around 50000 in France. In most cases, these deaths are due to myocardial infarction. This complication occurs, for 70% of cases, at the patient's residence, within 30 minutes following the thoracic pain. Emergency care often comes too late and allows only 2% of the patients having a heart failure to be revitalized.
At equal sex, age and clinical status, patients may or not develop ventricular rhythm disorders. Then, the notions of risk background and genetic disposition should be investigated.
No prospective study has been conducted on a sufficient number of patients yet. Such a study and the recent development of new genetic technologies will help identifying markers of sudden death risk at the acute phase of myocardial infarction.
The study we are implementing will increase knowledge on sudden death mechanisms at the acute phase of myocardial infarction. The analysis of phenotypic/genotypic relations will lead to an identification of new risk markers. Further evaluations of new diagnostic and therapeutic strategies will be possible on the basis of this trial.
Ventricular fibrillation at the acute phase of myocardial infarction follows a polygenic determinism. The genes involved in this electrical trouble are those which lead to the expression of potassic, calcic and sodic channels of ventricular myocytes: KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2, KCNJ2, PRKAG2, RyR2, PKP2, DSP, CASQ2, CACNA1C, and FKBP1B.
An association of a favourable genetic background and ischemia represents a cause for ventricular arrhythmia as a complication of myocardial infarction.
Haplotypes or genes considered as new markers for sudden death risk of ischemic origin will be searched.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: Blood sample500 patients with ventricular fibrillation at the acute phase of myocardial infarct |
| 2 | – | Genetic: Blood sample500 patients without ventricular fibrillation at the acute phase of myocardial infarct. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct, Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.
Key inclusion criteria (4 listed)
- All patients admitted to ICU for MI and presenting the following criteria:
- Age > 18
- Group 1 (Case) Patients with cardiac arrest and ventricular fibrillation developed up to 24 h post MI Group 2 (control) Patients with MI (no ventricular fibrillation)
- Written informed consent.
Key exclusion criteria (2 listed)
- No written informed consent
- Known Medical History of cardiomyopathy, including acute coronary syndrome
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 |
|---|---|---|
| Blood sampleBlood sample Determination of genetic background | Genetic | 1 |
| Blood sampleBlood sample Determination of genetic background | Genetic | 2 |
Primary outcome
Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.
Time frame: Correlation phenotype/genotype
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 36926933Chevalier P, Roy P, Bessiere F, Morel E, Ankou B, Morgan G, Halder I, London B, Minobe WA, Slavov D, Deliniere A, Bochaton T, Paganelli F, Lesavre N, Boiteux C, Mansourati J, Maury P, Clerici G, Winum PF, Huebler SP, Carroll IA, Bristow MR. Impact of Neuroeffector Adrenergic Receptor Polymorphisms on Incident Ventricular Fibrillation During Acute Myocardial Ischemia. J Am Heart Assoc. 2023 Mar 21;12(6):e025368. doi: 10.1161/JAHA.122.025368. Epub 2023 Mar 16.
- Derived from this study: PubMed 35942675Chevalier P, Moreau A, Bessiere F, Richard S, Chahine M, Millat G, Morel E, Paganelli F, Lesavre N, Placide L, Montestruc F, Ankou B, Puertas RD, Asatryan B, Deliniere A; MAP-IDM Investigators. Identification of Cx43 variants predisposing to ventricular fibrillation in the acute phase of ST-elevation myocardial infarction. Europace. 2023 Feb 8;25(1):101-111. doi: 10.1093/europace/euac128.
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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.
CHEVALIER Philippe, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Hospices Civils de Lyon 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct. (time frame: Correlation phenotype/genotype). 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 NCT00859300, which also lists 2 linked publications.
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 16 Mar 2016.