The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- Descriptive Data
Study Overview
Brief Summary
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.
Detailed Description
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals who have been cared for at Mayo Clinic with a diagnosis of SCAD
- •SCAD in women who are pregnant or within 12 months postpartum at the time of SCAD
- •SCAD in individuals who self-identify as a member of a racial or ethnic group that is currently underrepresented in the registry. This would include anyone who identifies as: Black/African American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and any race with Hispanic ethnicity
- •SCAD in a man
- •SCAD in persons younger than 30 years of age
- •SCAD within the past 2 weeks (acute)
- •SCAD patient enrolling into any other Mayo Clinic SCAD Research Study
- •SCAD in individuals who have a relative that has had a SCAD event
- •Persons with history of SCAD who are interested in participating in the study but do not meet the updated inclusion criteria will not be enrolled at this time. However, they will be given the option to share their contact information in order to be invited to future Mayo Clinic SCAD studies.
Exclusion Criteria
- Not provided
Arms & Interventions
SCAD Registry
Individuals who have experienced at least one episode of spontaneous coronary artery dissection.
Outcomes
Primary Outcomes
Descriptive Data
Time Frame: Continuous time frame following index event for 2-10 years from study contact date.
Obtain data regarding SCAD related risk factors, presenting characteristics, treatments and long term outcomes.
Secondary Outcomes
- Mental Health Update(Continuous time frame following index event for 2-10 years from study contact date.)
- Physical Health Update(Continuous time frame following index event for 2-10 years from study contact date.)
Investigators
Marysia Tweet
Principal Investigator
Mayo Clinic