Clinical trial NCT03941184: Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
Official title: Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: spontaneous coronary artery dissection
autoimmune
incidence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: Odds of autoimmune disease in SCAD cases compared to controls
timeFrame: Through study completion, or approximately 50 years (average age of study participants)
measure: Incidence Rate of SCAD
timeFrame: Through study completion, or approximately 50 years (average age of study participants)
Secondary outcomes:
measure: SCAD recurrence
timeFrame: Through study completion, or approximately 50 years (average age of study participants)
Other outcomes:
measure: Odds of laboratory markers for autoimmune disease in SCAD cases compared to controls
timeFrame: Through study completion, or approximately 50 years (average age of study participants)
measure: Odds of validated rheumatoid arthritis in SCAD cases compared to controls
timeFrame: Through study completion, or approximately 50 years (average age of study participants)
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Tweet MS, Hayes SN, Pitta SR, Simari RD, Lerman A, Lennon RJ, Gersh BJ, Khambatta S, Best PJ, Rihal CS, Gulati R. Clinical features, management, and prognosis of spontaneous coronary artery dissection. Circulation. 2012 Jul 31;126(5):579-88. doi: 10.1161/CIRCULATIONAHA.112.105718. Epub 2012 Jul 16.
citation: McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006 Aug;3(8):e297. doi: 10.1371/journal.pmed.0030297.
citation: St Sauver JL, Grossardt BR, Yawn BP, Melton LJ 3rd, Pankratz JJ, Brue SM, Rocca WA. Data resource profile: the Rochester Epidemiology Project (REP) medical records-linkage system. Int J Epidemiol. 2012 Dec;41(6):1614-24. doi: 10.1093/ije/dys195. Epub 2012 Nov 18.
citation: Tweet MS, Kok SN, Hayes SN. Spontaneous coronary artery dissection in women: What is known and what is yet to be understood. Clin Cardiol. 2018 Feb;41(2):203-210. doi: 10.1002/clc.22909. Epub 2018 Mar 1.
citation: Hayes SN, Kim ESH, Saw J, Adlam D, Arslanian-Engoren C, Economy KE, Ganesh SK, Gulati R, Lindsay ME, Mieres JH, Naderi S, Shah S, Thaler DE, Tweet MS, Wood MJ; American Heart Association Council on Peripheral Vascular Disease; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; and Stroke Council. Spontaneous Coronary Artery Dissection: Current State of the Science: A Scientific Statement From the American Heart Association. Circulation. 2018 May 8;137(19):e523-e557. doi: 10.1161/CIR.0000000000000564. Epub 2018 Feb 22.
citation: Adlam D, Alfonso F, Maas A, Vrints C; Writing Committee. European Society of Cardiology, acute cardiovascular care association, SCAD study group: a position paper on spontaneous coronary artery dissection. Eur Heart J. 2018 Sep 21;39(36):3353-3368. doi: 10.1093/eurheartj/ehy080. No abstract available.
citation: Waterbury TM, Tweet MS, Hayes SN, Eleid MF, Bell MR, Lerman A, Singh M, Best PJM, Lewis BR, Rihal CS, Gersh BJ, Gulati R. Early Natural History of Spontaneous Coronary Artery Dissection. Circ Cardiovasc Interv. 2018 Sep;11(9):e006772. doi: 10.1161/CIRCINTERVENTIONS.118.006772.
citation: Tweet MS, Eleid MF, Best PJ, Lennon RJ, Lerman A, Rihal CS, Holmes DR Jr, Hayes SN, Gulati R. Spontaneous coronary artery dissection: revascularization versus conservative therapy. Circ Cardiovasc Interv. 2014 Dec;7(6):777-86. doi: 10.1161/CIRCINTERVENTIONS.114.001659. Epub 2014 Nov 18.
citation: Tweet MS, Hayes SN, Codsi E, Gulati R, Rose CH, Best PJM. Spontaneous Coronary Artery Dissection Associated With Pregnancy. J Am Coll Cardiol. 2017 Jul 25;70(4):426-435. doi: 10.1016/j.jacc.2017.05.055.