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

Recruiting

• Conditions: SCAD; Spontaneous Coronary Artery Dissection

• Registration Number: NCT01429727
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Read More

Exclusion Criteria

• Lack of angiographic confirmation of SCAD
• Iatrogenic dissection or an alternate diagnosis

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive Data	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 Outcome Measures

Name	Time	Method
Mental Health Update	Continuous time frame following index event for 2-10 years from study contact date.	Record update on patient's current mental health status since the initial SCAD event.
Physical Health Update	Continuous time frame following index event for 2-10 years from study contact date.	Record update on patient's current physical health and any relevant health events that may have occurred since the initial SCAD event.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States