Myocardial InfarctionFASTMI2015NCT02566200
French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015
An observational study of Myocardial Infarction, run by French Cardiology Society at 1 site in France.
Trial summary
Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patient hospitalized in an intensive care unit in France for an acute myocardial infarction
Who may be able to join
- Male or female aged over 18 years
- Patients admitted within 48 hours of onset of symptoms in a coronary intensive care unit (USIC) for acute myocardial infarction (MI) defined by:
- A rise and fall of typical troponin (or CPKMb) associated with at least one of the following:
- symptoms consistent with myocardial ischemia
- development of pathological Q waves
- repolarisation disorders related to ischemia (or in addition to ST depression, T wave inversion)
- And having agreed to participate in the study.
Who cannot join
- Refusal to consent
- MI occurring in the 48 hours after therapeutic intervention (bypass surgery or coronary angioplasty or other surgical procedure)
- Diagnosis of myocardial reversed in favor of an alternative diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive care unit for acute myocardial infarction are relatively little studied exhaustively.
The study of clinical, biological and genetic characteristics of patients and their conditions of care, help to identify patients at risk for increased morbidity and mortality after myocardial infarction and could be the basis for the subsequent realization of specific studies on the optimal therapeutic management of the disease according to the different risk profiles.
Read the detailed description
This is a multicenter observational study, given to 300 prospective medical facilities, including a clinic or intensive care unit entitled to receive emergency acute coronary syndromes.
Patients will be recruited consecutively during a period of 2 months.
Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.
The ambition of the 2015 Observatory of the French Society of Cardiology is through a photograph "scale" of the practices in France at present, to ensure consistency in the quality of care for hospitalized patients heart attack; the investigation will emphasize the strengths but also the weaknesses of our health care system so that should improve. Finally, the observation of a large population of the real world will give the opportunity to assess the interactions between the different types of treatments used and check their possible synergy or incompatibilities.
- Conditions
- Myocardial Infarction
- Keywords
- Acute coronary syndrome, Cardiology
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IM group | Patients admitted in intensive care for a myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality 1 year after hospitalization for a myocardial infarction
Measured: 1 year after hospitalization
Secondary outcomes (2)
All cause mortality 10 years after hospitalization for a myocardial infarction
Measured: 10 years after hospitalization
To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications.
Measured: 10 years after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2017
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Nicolas Danchin, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566200
- Sponsor's protocol ID
- 15597
- Acronym
- FASTMI2015
- Status last verified
- Feb 2025
- First submitted
- 30 Sep 2015
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labeque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Gueret P, Belle L, Aissaoui N, Ferrieres J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.
PubMed 28844989Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labeque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrieres J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.
PubMed 28647465Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969. No abstract available.
PubMed 29784688Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labeque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrieres J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.
PubMed 31181374Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug-Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.
PubMed 31126738Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
PubMed 30538057Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.
PubMed 30536449Fayol A, Schiele F, Ferrieres J, Puymirat E, Bataille V, Tea V, Chamandi C, Albert F, Lemesle G, Cayla G, Weizman O, Simon T, Danchin N; FAST-MI Investigators. Association of Use and Dose of Lipid-Lowering Therapy Post Acute Myocardial Infarction With 5-Year Survival in Older Adults. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010685. doi: 10.1161/CIRCOUTCOMES.123.010685. Epub 2024 Apr 29.
PubMed 38682335Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Dec 14;43(47):4887-4896. doi: 10.1093/eurheartj/ehac579.
PubMed 36303402Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrieres J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.
PubMed 30354592
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015
- ClinicalTrials.gov ID
- NCT02566200
- Acronym / sponsor ID
- FASTMI2015 / 15597
- Conditions
- Myocardial Infarction
- Keywords
- Acute coronary syndrome, Cardiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 2 Oct 2015 (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.
Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive care unit for acute myocardial infarction are relatively little studied exhaustively.
The study of clinical, biological and genetic characteristics of patients and their conditions of care, help to identify patients at risk for increased morbidity and mortality after myocardial infarction and could be the basis for the subsequent realization of specific studies on the optimal therapeutic management of the disease according to the different risk profiles.
Detailed description
This is a multicenter observational study, given to 300 prospective medical facilities, including a clinic or intensive care unit entitled to receive emergency acute coronary syndromes.
Patients will be recruited consecutively during a period of 2 months.
Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.
The ambition of the 2015 Observatory of the French Society of Cardiology is through a photograph "scale" of the practices in France at present, to ensure consistency in the quality of care for hospitalized patients heart attack; the investigation will emphasize the strengths but also the weaknesses of our health care system so that should improve. Finally, the observation of a large population of the real world will give the opportunity to assess the interactions between the different types of treatments used and check their possible synergy or incompatibilities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM group | – | –Patients admitted in intensive care for a myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in an intensive care unit in France for an acute myocardial infarction
Key inclusion criteria (7 listed)
- Male or female aged over 18 years
- Patients admitted within 48 hours of onset of symptoms in a coronary intensive care unit (USIC) for acute myocardial infarction (MI) defined by:
- A rise and fall of typical troponin (or CPKMb) associated with at least one of the following:
- And having agreed to participate in the study.
Key exclusion criteria (3 listed)
- Refusal to consent
- MI occurring in the 48 hours after therapeutic intervention (bypass surgery or coronary angioplasty or other surgical procedure)
- Diagnosis of myocardial reversed in favor of an alternative diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality 1 year after hospitalization for a myocardial infarction
Time frame: 1 year after hospitalization
2 secondary outcomes
All cause mortality 10 years after hospitalization for a myocardial infarction
Time frame: 10 years after hospitalization
To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications.
Time frame: 10 years after hospitalization
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 7 Feb 2025.
- Results publication: PubMed 28844989Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labeque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Gueret P, Belle L, Aissaoui N, Ferrieres J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.
- Results publication: PubMed 28647465Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labeque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrieres J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.
- Results publication: PubMed 29784688Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969. No abstract available.
- Results publication: PubMed 31181374Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labeque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrieres J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.
- Results publication: PubMed 31126738Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug-Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.
- Results publication: PubMed 30538057Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
- Results publication: PubMed 30536449Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.
- Derived from this study: PubMed 38682335Fayol A, Schiele F, Ferrieres J, Puymirat E, Bataille V, Tea V, Chamandi C, Albert F, Lemesle G, Cayla G, Weizman O, Simon T, Danchin N; FAST-MI Investigators. Association of Use and Dose of Lipid-Lowering Therapy Post Acute Myocardial Infarction With 5-Year Survival in Older Adults. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010685. doi: 10.1161/CIRCOUTCOMES.123.010685. Epub 2024 Apr 29.
- Derived from this study: PubMed 36303402Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Dec 14;43(47):4887-4896. doi: 10.1093/eurheartj/ehac579.
- Derived from this study: PubMed 30354592Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrieres J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Nicolas Danchin principal investigator
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?
An observational study of Myocardial Infarction, run by French Cardiology Society 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 3 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 7 Feb 2025. 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?
All cause mortality 1 year after hospitalization for a myocardial infarction (time frame: 1 year after hospitalization). 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 NCT02566200, which also lists 10 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 7 Feb 2025.