Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

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

Sponsors

Lead Sponsor: Mayo Clinic

Source Mayo Clinic
Brief Summary

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.

Overall Status Recruiting
Start Date January 1, 1995
Completion Date March 15, 2021
Primary Completion Date December 31, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Odds of autoimmune disease in SCAD cases compared to controls Through study completion, or approximately 50 years (average age of study participants)
Incidence Rate of SCAD Through study completion, or approximately 50 years (average age of study participants)
Secondary Outcome
Measure Time Frame
SCAD recurrence Through study completion, or approximately 50 years (average age of study participants)
Enrollment 600
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Location
Facility: Status: Contact: Investigator: Mayo Clinic Vanessa L Kronzer, MD, MSCI 507-284-2511 [email protected] Vanessa L Kronzer, MD, MSCI Sub-Investigator Marysia S Tweet, MD Principal Investigator Cynthia S Crowson, PhD Sub-Investigator Elena Myasoedova, MD PhD Sub-Investigator Nicholas Tan, MD MS Sub-Investigator John Davis, MD MS Sub-Investigator Sharonne N Hayes, MD Sub-Investigator Rajiv Gulati, MD PhD Sub-Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: Marysia Tweet

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: SCAD cases

Description: 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).

Label: Controls without SCAD

Description: Potential controls will be identified based on absence of any SCAD diagnosis codes.

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Retrospective

Source: ClinicalTrials.gov