Myocardial InfarctionRIGID-MINCT04058782
Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
An observational study of Myocardial Infarction and Vascular Stiffness, run by University Hospital, Lille at 1 site in France.
Trial summary
Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Vascular Stiffness, Heart Failure
- What is being tested?
- Imaging evaluation for vascular assessment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2020to Mar 2030
- 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: All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. Over a 5-year period of time from 2019 to 2024. Planned population of 2000 patients. Follow-up every year by visit or phone contact up to 5 years.
Who may be able to join
- Signed informed consent
- Affiliated to national health insurance (French social security number)
- Presenting with MI within 48 hours of symptom onset
Who cannot join
- Patient under curatorship
- Type 2 MI
- Presenting with MI after 48 hours of symptom onset
- Pregnancy or lactating
- Refuse to participate
- No national health insurance (No French social security number)
Trial locations and contacts
1 site in 1 country.
About this study
Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.
- Conditions
- Myocardial Infarction, Vascular Stiffness, Heart Failure
- Being tested
- Imaging evaluation for vascular assessment
- Keywords
- Prognosis, Vascular stiffness, Heart failure, Myocardial infarction
- Medical subject headings
- Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging evaluation for vascular assessmentOther
At 1month after MI, Blood sample for total blood, plasma and PBMC collection, ECG, 3D-trans thoracic echocardiography for ventriculo-arterial coupling assessment, Vascular doppler for peripheral artery disease assessment, Arterial stiffness evaluation, Bilateral transcranial doppler for HITS evaluation
| Study group | Role | What they receive |
|---|---|---|
| Patients with myocardial | Not described Receives: Other: Imaging evaluation for vascular assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE: Major adverse cardiovascular events
A composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure
Measured: at 5 years
Secondary outcomes (12)
Cardiovascular death
Measured: at 5 years
Myocardial infarction
Measured: at 5 years
Ischemic stroke
Measured: at 5 years
Systemic embolism
Measured: at 5 years
Acute limb ischemia
Measured: at 5 years
Coronary revascularization
Measured: at 5 years
Hospitalization for heart failure
Measured: at 5 years
All-cause death
Measured: at 5 years
Bleeding as assessed by Bleeding Academic Research Consortium (BARC)
Measured: at 5 years
Bleeding as assessed by GUSTO Bleeding Criteria
Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) definition for bleeding range to 1. Severe or Life-threatening/ 2. Moderate/ 3. Mild
Measured: at 5 years
Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria
Measured: at 5 years
Bleeding as assessed by ISTH definitions
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start17 Feb 2020
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
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 University Hospital, LilleThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gilles Lemesle, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058782
- Sponsor's protocol ID
- 2018_43
- Other IDs
- 2018-A03276-49
- Acronym
- RIGID-MI
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04058782
- Acronym / sponsor ID
- RIGID-MI / 2018_43
- Conditions
- Myocardial Infarction, Vascular Stiffness, Heart Failure
- Keywords
- Prognosis, Vascular stiffness, Heart failure, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Merck Sharp & Dohme LLC
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Aug 2019 (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.
Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with myocardial | – | Other: Imaging evaluation for vascular assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. Over a 5-year period of time from 2019 to 2024. Planned population of 2000 patients. Follow-up every year by visit or phone contact up to 5 years.
Key inclusion criteria (3 listed)
- Signed informed consent
- Affiliated to national health insurance (French social security number)
- Presenting with MI within 48 hours of symptom onset
Key exclusion criteria (6 listed)
- Patient under curatorship
- Type 2 MI
- Presenting with MI after 48 hours of symptom onset
- Pregnancy or lactating
- Refuse to participate
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 |
|---|---|---|
| Imaging evaluation for vascular assessmentAt 1month after MI, Blood sample for total blood, plasma and PBMC collection, ECG, 3D-trans thoracic echocardiography for ventriculo-arterial coupling assessment, Vascular doppler for peripheral artery disease assessment, Arterial stiffness evaluation, Bilateral transcranial doppler for HITS evaluation | Other | Patients with myocardial |
Primary outcome
MACE: Major adverse cardiovascular events
Time frame: at 5 years
A composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure
12 secondary outcomes
Cardiovascular death
Time frame: at 5 years
Myocardial infarction
Time frame: at 5 years
Ischemic stroke
Time frame: at 5 years
Systemic embolism
Time frame: at 5 years
Acute limb ischemia
Time frame: at 5 years
Coronary revascularization
Time frame: at 5 years
Hospitalization for heart failure
Time frame: at 5 years
All-cause death
Time frame: at 5 years
Bleeding as assessed by Bleeding Academic Research Consortium (BARC)
Time frame: at 5 years
Bleeding as assessed by GUSTO Bleeding Criteria
Time frame: at 5 years
Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria
Time frame: at 5 years
Bleeding as assessed by ISTH definitions
Time frame: at 5 years
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 24 Apr 2026.
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.
Gilles Lemesle, MD principal investigator
University Hospital, Lille
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 and Vascular Stiffness, run by University Hospital, Lille 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 6 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 24 Apr 2026. 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?
MACE: Major adverse cardiovascular events (time frame: at 5 years). 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 24 Apr 2026.