We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spontaneous Coronary Artery Dissection National Swiss Registry (SwissSCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457544
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Sophie Degrauwe, University Hospital, Geneva

Brief Summary:

Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.

Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.

In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.


Condition or disease
Spontaneous Coronary Artery Dissection

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2030

Resource links provided by the National Library of Medicine


Group/Cohort
Retrospective patients
The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm.
Prospective patients
Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm.



Primary Outcome Measures :
  1. Primary objective [ Time Frame: 5 years ]
    Collect demographic and procedural data from consecutive SCAD patients in Switzerland.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

This observational study will recruit consecutive male and female patients presenting with newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years.

For the purposes of study inclusion, the definition of SCAD will be based on a central review of the coronary angiographic images confirmed by 2 independent assessors

Criteria

Inclusion Criteria:

  • Subject is ≥18 years of age.
  • Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
  • Subject must be willing to sign a Patient Informed Consent (PIC).

Exclusion Criteria:

  • Patient unwilling or unable to provide informed consent.
  • Patients with atherosclerotic or iatrogenic coronary dissection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457544


Contacts
Layout table for location contacts
Contact: Sophie Degrauwe, Dr +41795530294 sophie.degrauwe@hcuge.ch
Contact: Veronique Menoni, PhD +41795530917 Veronique.Menoni@hcuge.ch

Locations
Layout table for location information
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1205
Contact: Sophie Degrauwe, MD       sophie.degrauwe@hcuge.ch   
Contact: Véronique Menoni       veronique.menoni@hcuge.ch   
Sponsors and Collaborators
Dr. Sophie Degrauwe
Investigators
Layout table for investigator information
Principal Investigator: Sophie Degrauwe, Dr Hopitaux universitaires de Geneve
Layout table for additonal information
Responsible Party: Dr. Sophie Degrauwe, Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04457544    
Other Study ID Numbers: 2019-01886
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm, Dissecting
Coronary Vessel Anomalies
Vascular Diseases
Aneurysm
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities