- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941184
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
November 20, 2020 updated by: Marysia Tweet, Mayo Clinic
Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
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.
Study Overview
Status
Completed
Conditions
- Multiple Sclerosis
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Uveitis
- Vasculitis
- Psoriasis
- Graves Disease
- Systemic Sclerosis
- Celiac Disease
- Crohn Disease
- Type 1 Diabetes Mellitus
- Myasthenia Gravis
- Ulcerative Colitis
- Dermatomyositis
- Polymyositis
- Vitiligo
- Hepatitis, Autoimmune
- Polymyalgia Rheumatica
- Takayasu Arteritis
- Guillain-Barre Syndrome
- Ankylosing Spondylitis
- Hashimoto Thyroiditis
- Addison Disease
- SCAD
- Antiphospholipid Antibody Syndrome
- Primary Biliary Cirrhosis
- Raynaud
- Sjögren Syndrome
- Pernicious Anemia
Study Type
Observational
Enrollment (Actual)
114
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 108 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Odds of autoimmune disease in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
|
Through study completion, or approximately 50 years (average age of study participants)
|
Incidence Rate of SCAD
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
|
Through study completion, or approximately 50 years (average age of study participants)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SCAD recurrence
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
|
Through study completion, or approximately 50 years (average age of study participants)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Odds of laboratory markers for autoimmune disease in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
|
Through study completion, or approximately 50 years (average age of study participants)
|
|
Odds of validated rheumatoid arthritis in SCAD cases compared to controls
Time Frame: Through study completion, or approximately 50 years (average age of study participants)
|
using the Rochester Epidemiology Project Rheumatoid Arthritis cohort
|
Through study completion, or approximately 50 years (average age of study participants)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006 Aug;3(8):e297. doi: 10.1371/journal.pmed.0030297.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 1995
Primary Completion (Actual)
November 10, 2020
Study Completion (Actual)
November 10, 2020
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
May 3, 2019
First Posted (Actual)
May 7, 2019
Study Record Updates
Last Update Posted (Actual)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Neoplasms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neoplasms by Site
- Eye Diseases
- Endocrine System Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Gastrointestinal Diseases
- Diabetes Mellitus
- Liver Diseases
- Nutrition Disorders
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Arthritis
- Thyroid Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Intestinal Diseases
- Anemia
- Uveal Diseases
- Skin Diseases, Vascular
- Hepatitis, Chronic
- Nervous System Neoplasms
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Fibrosis
- Spinal Diseases
- Bone Diseases
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Lacrimal Apparatus Diseases
- Malabsorption Syndromes
- Biliary Tract Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Spondylarthritis
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Pigmentation Disorders
- Vitamin B Deficiency
- Myositis
- Aneurysm
- Hypopigmentation
- Hepatitis
- Bile Duct Diseases
- Vasculitis, Central Nervous System
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Adrenal Gland Diseases
- Bone Diseases, Infectious
- Ankylosis
- Aortic Diseases
- Polyradiculoneuropathy
- Polyneuropathies
- Cholestasis, Intrahepatic
- Cholestasis
- Liver Cirrhosis
- Adrenal Insufficiency
- Thyroiditis, Autoimmune
- Anemia, Megaloblastic
- Anemia, Macrocytic
- Vitamin B 12 Deficiency
- Multiple Sclerosis
- Sclerosis
- Syndrome
- Diabetes Mellitus, Type 1
- Vascular Diseases
- Lupus Erythematosus, Systemic
- Scleroderma, Systemic
- Celiac Disease
- Crohn Disease
- Myasthenia Gravis
- Aneurysm, Dissecting
- Dermatomyositis
- Vitiligo
- Hepatitis, Autoimmune
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
- Vasculitis
- Sjogren's Syndrome
- Antiphospholipid Syndrome
- Uveitis
- Spondylitis
- Spondylitis, Ankylosing
- Takayasu Arteritis
- Aortic Arch Syndromes
- Polymyositis
- Guillain-Barre Syndrome
- Liver Cirrhosis, Biliary
- Hashimoto Disease
- Graves Disease
- Thyroiditis
- Coronary Vessel Anomalies
- Addison Disease
- Anemia, Pernicious
Other Study ID Numbers
- 19-002489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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