Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03941184

Collaborator

(none)

114

Enrollment

Location

310.3

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SCAD Addison Disease Ankylosing Spondylitis Antiphospholipid Antibody Syndrome Celiac Disease Crohn Disease Dermatomyositis Polymyositis Guillain-Barre Syndrome Hepatitis, Autoimmune Graves Disease Hashimoto Thyroiditis Multiple Sclerosis Myasthenia Gravis Pernicious Anemia Polymyalgia Rheumatica Primary Biliary Cirrhosis Psoriasis Rheumatoid Arthritis Systemic Sclerosis Sjögren Syndrome Systemic Lupus Erythematosus Takayasu Arteritis Type 1 Diabetes Mellitus Ulcerative Colitis Uveitis Vasculitis Vitiligo Raynaud

Study Design

Study Type:

Observational

Actual Enrollment :

114 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 1995

Actual Primary Completion Date :

Nov 10, 2020

Actual Study Completion Date :

Nov 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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 Measures

SCAD recurrence [Through study completion, or approximately 50 years (average age of study participants)]

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

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.