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NCT03941184 Clinical Trial

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03941184
Other study ID # 19-002489
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 1995
Est. completion date November 10, 2020

Study information
Verified date November 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date November 10, 2020
Est. primary completion date November 10, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 110 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Addison Disease
  • Aneurysm, Dissecting
  • Ankylosing Spondylitis
  • Antiphospholipid Antibody Syndrome
  • Antiphospholipid Syndrome
  • Arteritis
  • Celiac Disease
  • Crohn Disease
  • Dermatomyositis
  • Diabetes Mellitus, Type 1
  • Giant Cell Arteritis
  • Graves Disease
  • Guillain-Barre Syndrome
  • Hashimoto Disease
  • Hashimoto Thyroiditis
  • Hepatitis, Autoimmune
  • Liver Cirrhosis, Biliary
  • Lupus Erythematosus, Systemic
  • Multiple Sclerosis
  • Myasthenia Gravis
  • Pernicious Anemia
  • Polymyalgia Rheumatica
  • Polymyositis
  • Primary Biliary Cirrhosis
  • Psoriasis
  • Raynaud
  • Rheumatoid Arthritis
  • SCAD
  • Scleroderma, Systemic
  • Sclerosis
  • Sjögren Syndrome
  • Sjogren's Syndrome
  • Spondylitis
  • Spondylitis, Ankylosing
  • Syndrome
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Takayasu Arteritis
  • Thyroiditis
  • Type 1 Diabetes Mellitus
  • Ulcerative Colitis
  • Uveitis
  • Vasculitis
  • Vitiligo

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. Review. — View Citation

McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006 Aug;3(8):e297. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other 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)
Other Odds of validated rheumatoid arthritis in SCAD cases compared to controls using the Rochester Epidemiology Project Rheumatoid Arthritis cohort Through study completion, or approximately 50 years (average age of study participants)
Primary Odds of autoimmune disease in SCAD cases compared to controls Through study completion, or approximately 50 years (average age of study participants)
Primary Incidence Rate of SCAD Through study completion, or approximately 50 years (average age of study participants)
Secondary SCAD recurrence Through study completion, or approximately 50 years (average age of study participants)
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