Myocardial InfarctionMODIFNCT04357314
Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
An observational study of Myocardial Infarction, run by French Cardiology Society at 1 site in France.
Trial summary
In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 6,332 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 May 2020
- 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: Patients presenting to the hospital with acute coronary syndrome
Who may be able to join
- Patients admitted on coronary angiography room for acute coronary syndrome with ST segment elevation defined by the following criteria:
- Symptoms suggestive of myocardial ischemia (ex: persistent chest pain) AND
- An elevation of the ST segment (measured from point J) visible on at least two contiguous leads with an elevation ≥ 2.5 millimeters in men <40 years, or ≥ 2 millimeters in men ≥ 40 years, or ≥ 1.5 millimeters in women in V2-V3 leads and / or ≥ 1 millimeter in other leads (in the absence of branch block).
Who cannot join
- 121/5000
- Contraindication to invasive management related to the general condition of the patient.
- Minors
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.
Read the detailed description
The aim of this study is to investigate the rates and characteristics of patients presenting with acute myocardial infarction between march 1, 2020 to May 31, 2020 and compared those data with those of this year (march 1, 2019 to May 31, 2019).
The following elements will aslo been collected:
- Clinical presentation
- Mode of admission (SAMU (Service d'Aide Médicale Urgente in French ie Emergency Medical Aid Service) / emergency department / in hospital)
- Call for SAMU : delay, number of calls, response
- Thrombolysis
- Delays (symptom onset to first medical contact / door to balloon)
- Final Result : TIMI (Thrombolysis In Myocardial Infarction)
- COVID-19 status if known
- Underlying known ischemic cardiopathy
- ECG (electrocardiogram) Q waves.
- Complication after PCI (Percutaneous Coronary Intervention): Discharged date, LVEF (Left Ventricular Ejection Fraction), ventricular tachycardia Data will be collected through all participating centers under the supervision of the cath lab director.
- Conditions
- Myocardial Infarction
- Keywords
- Emergency care
- Medical subject headings
- Myocardial Infarction
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 |
|---|---|---|
| Patients with STEMI in 2019 | Patient with acute myocardial infarction between March 17, 2019 and April17, 2019 | |
| Patients with STEMI in 2020 | Patient with acute myocardial infarction between March 17, 2020 and April17, 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)
Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture
Measured: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Rates of patients presenting with acute myocardial infarction
Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020
Measured: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Secondary outcomes (8)
Patient profile during admission for acute myocardial infarction
Correlation between clinical patient profile and the degree of affection of regions by COVID-19
Measured: 3 months (between March 1 to May 31
Medical care times analysis
Correlation between the delay between onset of symptoms - first medical contact - coronary angiography room and the degree of affection of regions by COVID-19
Measured: 3 months (between March 1 to May 31)
Medical care times analysis
Delay in minutes from symptom onset and STEMI (ST Segment Elevation Myocardial Infarction) diagnosis; and delay in minutes from onset of symptoms and primary PCI (percutaneous coronary intervention)
Measured: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Clinical evolution of patients
Correlation between the fate of patient and the degree of affection of regions by COVID-19: Number of days in cardiology department, Left Ventricular Ejection Fraction at discharge, presence of hemodynamic complications, presence of mechanical complications, transfer to intensive care unit, infection with COVID-19 during hospitalization, living status at discharge
Measured: 3 months (between March 1 to May 31)
Clinical evolution of patients
Number of in hospital outcomes including orotracheal intubation, cardiogenic shock, arrhythmias (ventricular tachycardia of ventricular fibrillation) and in hospital cardiac arrest
Measured: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates
Number of patient admitted in cardiology department with STEMI (ST Segment Elevation Myocardial Infarction)
Measured: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Proportion of patients who underwent systemic thrombolysis
Correlation between the number of patients who underwent systemic thrombolysis and the degree of affection of regions by COVID-19
Measured: 3 months (between March 1 to May 31)
Proportion of patients infected with COVID-19
Number of patient admitted in cardiology department for acute myocardial infarction infected with COVID-19
Measured: 3 months (between March 1 to May 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
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.
- 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
- Retrospective
- Enrolment
- 6,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume CAYLA, MD, Study director, Hôpital Universitaire CarémeauGuillaume BONNET, MD, Principal investigator, Inserm 970
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357314
- Sponsor's protocol ID
- 2020-03
- Acronym
- MODIF
- Status last verified
- Aug 2020
- First submitted
- 19 Apr 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study
- ClinicalTrials.gov ID
- NCT04357314
- Acronym / sponsor ID
- MODIF / 2020-03
- Conditions
- Myocardial Infarction
- Keywords
- Emergency care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,332 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- 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.
In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.
Detailed description
The aim of this study is to investigate the rates and characteristics of patients presenting with acute myocardial infarction between march 1, 2020 to May 31, 2020 and compared those data with those of this year (march 1, 2019 to May 31, 2019).
The following elements will aslo been collected:
- Clinical presentation
- Mode of admission (SAMU (Service d'Aide Médicale Urgente in French ie Emergency Medical Aid Service) / emergency department / in hospital)
- Call for SAMU : delay, number of calls, response
- Thrombolysis
- Delays (symptom onset to first medical contact / door to balloon)
- Final Result : TIMI (Thrombolysis In Myocardial Infarction)
- COVID-19 status if known
- Underlying known ischemic cardiopathy
- ECG (electrocardiogram) Q waves.
- Complication after PCI (Percutaneous Coronary Intervention): Discharged date, LVEF (Left Ventricular Ejection Fraction), ventricular tachycardia Data will be collected through all participating centers under the supervision of the cath lab director.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with STEMI in 2019 | – | –Patient with acute myocardial infarction between March 17, 2019 and April17, 2019 |
| Patients with STEMI in 2020 | – | –Patient with acute myocardial infarction between March 17, 2020 and April17, 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the hospital with acute coronary syndrome
Key inclusion criteria (3 listed)
- Patients admitted on coronary angiography room for acute coronary syndrome with ST segment elevation defined by the following criteria:
- Symptoms suggestive of myocardial ischemia (ex: persistent chest pain) AND
- An elevation of the ST segment (measured from point J) visible on at least two contiguous leads with an elevation ≥ 2.5 millimeters in men <40 years, or ≥ 2 millimeters in men ≥ 40 years, or ≥ 1.5 millimeters in women in V2-V3 leads and / or ≥ 1 millimeter in other leads (in the absence of branch block).
Key exclusion criteria (4 listed)
- 121/5000
- Contraindication to invasive management related to the general condition of the patient.
- Minors
- Pregnant women
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
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)
Time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture
Rates of patients presenting with acute myocardial infarction
Time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020
8 secondary outcomes
Patient profile during admission for acute myocardial infarction
Time frame: 3 months (between March 1 to May 31
Medical care times analysis
Time frame: 3 months (between March 1 to May 31)
Medical care times analysis
Time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Clinical evolution of patients
Time frame: 3 months (between March 1 to May 31)
Clinical evolution of patients
Time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
STEMI (ST Segment Elevation Myocardial Infarction) admissions incidence rates
Time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )
Proportion of patients who underwent systemic thrombolysis
Time frame: 3 months (between March 1 to May 31)
Proportion of patients infected with COVID-19
Time frame: 3 months (between March 1 to May 31)
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 19 Aug 2020.
- 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.
Guillaume CAYLA, MD study director
Hôpital Universitaire Carémeau
Guillaume BONNET, MD principal investigator
Inserm 970
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 3 inclusion and 4 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 19 Aug 2020. 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?
The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI) (time frame: 3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )). 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 19 Aug 2020.