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The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.

NCT02799186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-01-24

No results posted yet for this study

Summary

Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.

The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection.

From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis.

For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected.

This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge.

Conditions

  • Spontaneous Coronary Artery Dissection
  • Spontaneous Coronary Artery Haematoma

Interventions

PROCEDURE

blood sample for genetic analysis

Sponsors & Collaborators

  • Heart and Research Foundation

    collaborator UNKNOWN

  • French Coronary Atheroma and Interventional Cardiology Group

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Pascal MOTREFF · University Hospital, Clermont-Ferrand

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-11-04
Completion
2019-11-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799186 on ClinicalTrials.gov