Ignite Creation Date:
2024-05-06 @ 8:41 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02799186
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2016-06-09
Brief Title:
The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCO
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A00403-48 | REGISTRY | 2016-A00403-48 | None |