Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

NCT ID: NCT03941184

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-01-01

Study Completion Date

2020-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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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

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spontaneous coronary artery dissection autoimmune incidence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Controls without SCAD

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Marysia Tweet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22800851 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16942393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23159830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29493808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29472380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29481627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30354594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25406203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28728686 (View on PubMed)

Related Links

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https://clinicaltrials.gov/ct2/show/NCT01429727

The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

https://clinicaltrials.gov/ct2/show/NCT01427179

Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

Other Identifiers

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19-002489

Identifier Type: -

Identifier Source: org_study_id