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

NCT02799186 | Completed

• 2 other identifiers: CHU-02672016-A00403-48
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Coronary Artery Dissection; Spontaneous Coronary Artery Haematoma

Keywords

Spontaneous Coronary Artery Dissection; haematoma; Fibromuscular Dysplasia; genetic analysis; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

  at day 1

Secondary Outcomes (5)

• Prevalence of the FMD in the population SCAD from a tomographic or MRI angiography analysis of renal, cerebrovascular and iliac arteries

  at day 1

• Hormonal Parameters ( gynecological factors)

  at day 1

• Environmental Factors : physical exercise or an recent intense emotional stress

  at day 1

• Genetic Factors (including recently identified genetic risk loci for FMD)

  at day 1

• Morbi-mortality to 1 year

  at 1 year

Study Arms (1)

SCAD (spontaneous coronary artery dissection)

EXPERIMENTAL

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

Interventions

blood sample for genetic analysis PROCEDURE

SCAD (spontaneous coronary artery dissection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Heart and Research Foundation: collaborator
• French Coronary Atheroma and Interventional Cardiology Group: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Hematoma; Fibromuscular Dysplasia; Acute Coronary Syndrome

Interventions

Blood Specimen Collection; Genetic Testing

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Pascal MOTREFF

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 24, 2022

Record last verified: 2016-06

Locations

FR (1)