Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

November 20, 2020 updated by: Marysia Tweet, Mayo Clinic

Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

Study Overview

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

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

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

16 years to 108 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Rochester Epidemiology Project (REP) is a population-based cohort that includes medical record data for over 500,000 unique individuals who resided in Olmsted County at some point between 1966 and the present, and received health care for any reason within the system (St. Sauver 2012).

Description

Inclusion Criteria:

  • Adults age 18 to 110
  • Residence in Olmsted County. Note: if sufficient numbers cannot be reached using only Olmsted County, will expand to the 27-county region.

Exclusion Criteria:

  • None

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: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
SCAD cases
SCAD cases will be identified based on presence of at least one diagnosis code for SCAD followed by manual verification by a trained individual, OR, inclusion in the previously validated SCAD cohort (Tweet 2012).
Controls without SCAD
Potential controls will be identified based on absence of any SCAD diagnosis codes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Odds of autoimmune disease in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
Through study completion, or approximately 50 years (average age of study participants)
Incidence Rate of SCAD
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
Through study completion, or approximately 50 years (average age of study participants)

Secondary Outcome Measures

Outcome Measure
Time Frame
SCAD recurrence
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
Through study completion, or approximately 50 years (average age of study participants)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds of laboratory markers for autoimmune disease in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
Through study completion, or approximately 50 years (average age of study participants)
Odds of validated rheumatoid arthritis in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
using the Rochester Epidemiology Project Rheumatoid Arthritis cohort
Through study completion, or approximately 50 years (average age of study participants)

Collaborators and Investigators

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

Sponsor

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

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 (Actual)

January 1, 1995

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

November 10, 2020

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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