Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

NCT03941184 | Completed

• 1 other identifier: 19-002489
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• SCAD recurrence

  Through study completion, or approximately 50 years (average age of study participants)

Other Outcomes (2)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (9)

• 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.

  PMID: 22800851 BACKGROUND

• McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006 Aug;3(8):e297. doi: 10.1371/journal.pmed.0030297.

  PMID: 16942393 BACKGROUND

• 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.

  PMID: 23159830 BACKGROUND

• 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.

  PMID: 29493808 BACKGROUND

• 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.

  PMID: 29472380 BACKGROUND

• 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.

  PMID: 29481627 BACKGROUND

• 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.

  PMID: 30354594 BACKGROUND

• 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.

  PMID: 25406203 BACKGROUND

• 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.

  PMID: 28728686 BACKGROUND

Related Links

• The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry
• Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

MeSH Terms

Conditions

Addison Disease; Spondylitis, Ankylosing; Antiphospholipid Syndrome; Celiac Disease; Crohn Disease; Dermatomyositis; Polymyositis; Guillain-Barre Syndrome; Hepatitis, Autoimmune; Graves Disease; Hashimoto Disease; Multiple Sclerosis; Myasthenia Gravis; Anemia, Pernicious; Polymyalgia Rheumatica; Liver Cirrhosis, Biliary; Psoriasis; Arthritis, Rheumatoid; Scleroderma, Systemic; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Takayasu Arteritis; Diabetes Mellitus, Type 1; Colitis, Ulcerative; Uveitis; Vasculitis; Vitiligo; Coronary Artery Dissection, Spontaneous

Condition Hierarchy (Ancestors)

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Chronic; Hepatitis; Liver Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Hyperthyroidism; Thyroiditis, Autoimmune; Thyroiditis; Demyelinating Autoimmune Diseases, CNS; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Anemia, Megaloblastic; Anemia, Macrocytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Vitamin B 12 Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Rheumatic Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Skin Diseases, Papulosquamous; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Skin Diseases, Vascular; Diabetes Mellitus; Glucose Metabolism Disorders; Colitis; Colonic Diseases; Uveal Diseases; Hypopigmentation; Pigmentation Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: May 7, 2019
• Study Start: January 1, 1995
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)