Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction (RIGID-MI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058782
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Fédération Française de Cardiologie
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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 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.

Condition or disease Intervention/treatment
Myocardial Infarction Vascular Stiffness Heart Failure Other: Imaging evaluation for vascular assessment

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with myocardial Other: Imaging evaluation for vascular assessment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: at 5 years ]
  2. Myocardial infarction [ Time Frame: at 5 years ]
  3. Ischemic stroke [ Time Frame: at 5 years ]
  4. Systemic embolism [ Time Frame: at 5 years ]
  5. Acute limb ischemia [ Time Frame: at 5 years ]
  6. Coronary revascularization [ Time Frame: at 5 years ]
  7. Hospitalization for heart failure [ Time Frame: at 5 years ]
  8. All-cause death [ Time Frame: at 5 years ]
  9. Bleeding as assessed by Bleeding Academic Research Consortium (BARC) [ Time Frame: at 5 years ]
  10. Bleeding as assessed by GUSTO Bleeding Criteria [ Time Frame: at 5 years ]
    Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) definition for bleeding range to 1. Severe or Life-threatening/ 2. Moderate/ 3. Mild

  11. Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: at 5 years ]
  12. Bleeding as assessed by ISTH definitions [ Time Frame: at 5 years ]

Biospecimen Retention:   Samples With DNA
Blood sample for total blood, plasma and peripheral blood mononuclear cell collection at 1-month.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Signed informed consent
  • Affiliated to national health insurance (French social security number)
  • Presenting with MI within 48 hours of symptom onset

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058782


Contacts
Layout table for location contacts
Contact: Gilles Lemesle, MD 03 20 44 45 61 ext +33 gilles.lemesle@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Fédération Française de Cardiologie
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Gilles Lemesle, MD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04058782     History of Changes
Other Study ID Numbers: 2018_43
2018-A03276-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Prognosis
Vascular stiffness
Heart failure
Myocardial infarction
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases