Myocardial InfarctionSTEMINCT02822638
Cohort of STEMI Patients
An observational study of Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. 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?
- STEMI PATIENT Cohort
- How many people
- 1,204 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to May 2016
- 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: STEMI PATIENT
Who may be able to join
- Age> 18 years
- Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
- Primary PCI within 12 hours of symptoms onset.
Who cannot join
- Diagnosis of STEMI not confirmed by angiography
- Refusal to participate in the study or to sign the consent
- Inability to give information to the subject about the study
- Lack of medical social coverage
- Deprivation of civil rights
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine
Bron, 69677
About this study
Official title: CoHort of STEMI Patients
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.
However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.
Read more
Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.
In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ….
This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.
The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.
- Conditions
- Myocardial Infarction
- Being tested
- STEMI PATIENT Cohort
- Keywords
- Myocardial infarction, biomarkers, STEMI
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEMI PATIENT CohortOther
PCI
| Study group | Role | What they receive |
|---|---|---|
| STEMI PATIENT Cohort | STEMI PATIENT Cohort Receives: Other: STEMI PATIENT Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Troponin
Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)
Measured: Day 0
Change in Creatine Kinase
Dosage of Creatine Kinase at hospital admission and 4 hours after PCI
Measured: Day 0
Secondary outcomes (2)
New York Heart Association (NYHA) Class
Measured: at admission (Day 0)
Left ventricular ejection fraction (LVEF)
LVEF measured by echocardiography
Measured: 24 hours after PCI (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startAug 2009
- Primary completionMay 2016
- Study completionMay 2016
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel OVIZE, Pr, Principal investigator, Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822638
- Sponsor's protocol ID
- 69HCL16_0412
- Acronym
- STEMI
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoHort of STEMI Patients
- ClinicalTrials.gov ID
- NCT02822638
- Acronym / sponsor ID
- STEMI / 69HCL16_0412
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, biomarkers, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Jul 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.
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.
However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.
Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.
In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ….
This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.
The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI PATIENT Cohort | – | Other: STEMI PATIENT CohortSTEMI PATIENT Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI PATIENT
Key inclusion criteria (3 listed)
- Age> 18 years
- Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
- Primary PCI within 12 hours of symptoms onset.
Key exclusion criteria (5 listed)
- Diagnosis of STEMI not confirmed by angiography
- Refusal to participate in the study or to sign the consent
- Inability to give information to the subject about the study
- Lack of medical social coverage
- Deprivation of civil rights
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 |
|---|---|---|
| STEMI PATIENT CohortPCI | Other | STEMI PATIENT Cohort |
Primary outcome
Change in Troponin
Time frame: Day 0
Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)
Change in Creatine Kinase
Time frame: Day 0
Dosage of Creatine Kinase at hospital admission and 4 hours after PCI
2 secondary outcomes
New York Heart Association (NYHA) Class
Time frame: at admission (Day 0)
Left ventricular ejection fraction (LVEF)
Time frame: 24 hours after PCI (Day 1)
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 4 Jul 2016.
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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.
Michel OVIZE, Pr principal investigator
Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON
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 3 inclusion and 5 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 4 Jul 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?
Change in Troponin (time frame: Day 0). 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 4 Jul 2016.