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Trial record 36 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

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ClinicalTrials.gov Identifier: NCT03941184
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Marysia Tweet, Mayo Clinic

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.

Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
Actual Study Start Date : January 1, 1995
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 15, 2020


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.



Primary Outcome Measures :
  1. Odds of autoimmune disease in SCAD cases compared to controls [ Time Frame: Through study completion, or approximately 50 years (average age of study participants) ]
  2. Incidence Rate of SCAD [ Time Frame: Through study completion, or approximately 50 years (average age of study participants) ]

Secondary Outcome Measures :
  1. SCAD recurrence [ Time Frame: Through study completion, or approximately 50 years (average age of study participants) ]

Other Outcome Measures:
  1. 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) ]
  2. 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



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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes 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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941184


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Vanessa L Kronzer, MD, MSCI    507-284-2511    kronzer.vanessa@mayo.edu   
Sub-Investigator: Vanessa L Kronzer, MD, MSCI         
Principal Investigator: Marysia S Tweet, MD         
Sub-Investigator: Cynthia S Crowson, PhD         
Sub-Investigator: Elena Myasoedova, MD PhD         
Sub-Investigator: Nicholas Tan, MD MS         
Sub-Investigator: John Davis, MD MS         
Sub-Investigator: Sharonne N Hayes, MD         
Sub-Investigator: Rajiv Gulati, MD PhD         
Sponsors and Collaborators
Mayo Clinic

Additional Information:
Publications:

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Responsible Party: Marysia Tweet, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03941184     History of Changes
Other Study ID Numbers: 19-002489
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marysia Tweet, Mayo Clinic:
spontaneous coronary artery dissection
autoimmune
incidence
Additional relevant MeSH terms:
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Hashimoto Disease
Spondylitis
Spondylitis, Ankylosing
Sjogren's Syndrome
Dermatomyositis
Polymyositis
Polymyalgia Rheumatica
Crohn Disease
Celiac Disease
Liver Cirrhosis, Biliary
Hepatitis, Autoimmune
Multiple Sclerosis
Myasthenia Gravis
Giant Cell Arteritis
Guillain-Barre Syndrome
Uveitis
Graves Disease
Vasculitis
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Aneurysm, Dissecting
Anemia, Pernicious
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Vitiligo
Diabetes Mellitus, Type 1
Thyroiditis
Addison Disease