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

January 7, 2022 updated by: University Hospital, Clermont-Ferrand

PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The recruitment of patients takes place in each interventional cardiology department.

The patients can be included in a retrospective way (for SCAD occurred from 2010) or forward-looking way. The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed.

Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria :

  • Patients over 18 year's old

  • Patient with a possible diagnosis of spontaneous coronary dissection defined by:

    • A picture of SCA
    • Compatible angiographic signs
    • More or less confirmed by intracoronary imaging (OCT/IVUS) or check angiographic control (upper to 1 month)
  • Patient having given his informed consent and signed to participate to the study
  • Subject accepting the use of its personal data in the form of an anonymous codification including in the scientific publications.

Exclusion Criteria:

  • - Minor patient
  • Major patient submitted to a protective measure (guardianship, supervision guardianship)
  • No affiliation to the French social security system
  • Coronary dissection with traumatic or iatrogenic origin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCAD (spontaneous coronary artery dissection)
Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France.
Procedure: blood sample for genetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of the SCAD in the population of patients taken care for a ACS
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of the FMD in the population SCAD from a tomographic or MRI angiography analysis of renal, cerebrovascular and iliac arteries
Time Frame: at day 1
at day 1
Hormonal Parameters ( gynecological factors)
Time Frame: at day 1
at day 1
Environmental Factors : physical exercise or an recent intense emotional stress
Time Frame: at day 1
at day 1
Genetic Factors (including recently identified genetic risk loci for FMD)
Time Frame: at day 1
at day 1
Morbi-mortality to 1 year
Time Frame: at 1 year
at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Heart and Research Foundation
French Coronary Atheroma and Interventional Cardiology Group

Investigators

  • Principal Investigator: Pascal MOTREFF, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

November 4, 2019

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0267
  • 2016-A00403-48 (Registry Identifier: 2016-A00403-48)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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