The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

This study is currently recruiting participants.
Verified November 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Sharonne Hayes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01429727
First received: August 30, 2011
Last updated: November 27, 2013
Last verified: November 2013

August 30, 2011
November 27, 2013
July 2011
December 2014   (final data collection date for primary outcome measure)
Descriptive Data [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]
Obtain data regarding SCAD related risk factors, presenting characteristics, treatments and long term outcomes.
Same as current
Complete list of historical versions of study NCT01429727 on ClinicalTrials.gov Archive Site
  • Physical Health Update [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]
    Record update on patient's current physical health and any relevant health events that may have occurred since the initial SCAD event.
  • Mental Health Update [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]
    Record update on patient's current mental health status since the initial SCAD event.
Same as current
Not Provided
Not Provided
 
The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry
The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event.

This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

Spontaneous Coronary Artery Dissection (SCAD) is a relatively rare and poorly understood condition that has been reported to affect more women than men. The coronary arteries consist of three layers, and dissection occurs when two of these layers separate, enabling blood to flow into the space between the layers. As the blood accumulates, this can cause obstruction to normal blood flow within the heart, leading to chest pain, heart attack and even sudden death.

The medical community has much to learn about treatment and prevention of this potentially fatal cardiovascular event. Mayo Clinic is conducting two new studies of SCAD. This study consists of building a database/registry of patients with SCAD (whether they have been patients at Mayo Clinic or not) to identify patterns of SCAD incidence, causes and associations that could guide future research. With participant consent, Mayo Clinic staff will request a copy of the original coronary angiogram when SCAD was diagnosed to confirm the diagnosis and determine eligibility. If eligible, study coordinators will contact the participant to provide more information about the studies and request a signed informed consent document.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

Men and women with spontaneous coronary artery dissection (SCAD) as confirmed on angiogram.

  • Spontaneous Coronary Artery Dissection
  • SCAD
Not Provided
SCAD Registry
Individuals who have experienced at least one episode of spontaneous coronary artery dissection.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women able to give informed consent
  • Diagnosis of one or more episodes of spontaneous coronary artery dissection (SCAD)

Exclusion Criteria:

  • Lack of angiographic confirmation of SCAD
  • Iatrogenic dissection or an alternate diagnosis
Both
18 Years and older
Yes
Contact: Jill Boyum 507-266-3180 mayoscad@mayo.edu
United States
 
NCT01429727
11-001852
No
Sharonne Hayes, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Sharonne N. Hayes, M.D. Mayo Clinic
Mayo Clinic
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP