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

Primary Purpose

Spontaneous Coronary Artery Dissection, Spontaneous Coronary Artery Haematoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample for genetic analysis
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spontaneous Coronary Artery Dissection focused on measuring Spontaneous Coronary Artery Dissection, haematoma, Fibromuscular Dysplasia, genetic analysis, Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCAD (spontaneous coronary artery dissection)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of the SCAD in the population of patients taken care for a ACS

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2016
Last Updated
January 7, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Heart and Research Foundation, French Coronary Atheroma and Interventional Cardiology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02799186
Brief Title
The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.
Acronym
DISCO
Official Title
PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Heart and Research Foundation, French Coronary Atheroma and Interventional Cardiology Group

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Coronary Artery Dissection, Spontaneous Coronary Artery Haematoma
Keywords
Spontaneous Coronary Artery Dissection, haematoma, Fibromuscular Dysplasia, genetic analysis, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCAD (spontaneous coronary artery dissection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
blood sample for genetic analysis
Primary Outcome Measure Information:
Title
Incidence of the SCAD in the population of patients taken care for a ACS
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
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
Title
Hormonal Parameters ( gynecological factors)
Time Frame
at day 1
Title
Environmental Factors : physical exercise or an recent intense emotional stress
Time Frame
at day 1
Title
Genetic Factors (including recently identified genetic risk loci for FMD)
Time Frame
at day 1
Title
Morbi-mortality to 1 year
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal MOTREFF
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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