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NCT Number: NCT04058782

Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Heart Failure Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Stiffness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Coeur-Poumon, CHU

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imaging evaluation for vascular assessment

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Fédération Française de Cardiologie
  • Merck Sharp & Dohme LLC

Registry information

Acronym: RIGID-MI

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Aug 16, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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