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

January 2, 2024 updated by: Sharonne Hayes, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Sharonne N. Hayes, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
SCAD Registry
Individuals who have experienced at least one episode of spontaneous coronary artery dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Continuous time frame following index event for 2-10 years from study contact date.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Health Update
Time Frame: 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.
Continuous time frame following index event for 2-10 years from study contact date.
Mental Health Update
Time Frame: 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.
Continuous time frame following index event for 2-10 years from study contact date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Sharonne N. Hayes, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimated)

September 7, 2011

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-001852

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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