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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Incidence of the SCAD in the population of patients taken care for a ACS [ Time Frame: at day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Hormonal Parameters ( gynecological factors) [ Time Frame: at day 1 ]
  • Environmental Factors : physical exercise or an recent intense emotional stress [ Time Frame: at day 1 ]
  • Genetic Factors (including recently identified genetic risk loci for FMD) [ Time Frame: at day 1 ]
  • Morbi-mortality to 1 year [ Time Frame: at 1 year ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: June 9, 2016
Date Started: May 2016
Date Completion: May 2020
Last Updated: June 9, 2016
Last Verified: June 2016