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出境医 / 临床实验 / Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Study Description
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

Study Design
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Study Type : Observational
Actual Enrollment : 114 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
Actual Primary Completion Date : November 10, 2020
Actual Study Completion Date : November 10, 2020
Arms 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.
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Tracking Information
First Submitted Date April 1, 2019
First Posted Date May 7, 2019
Last Update Posted Date November 23, 2020
Actual Study Start Date January 1, 1995
Actual Primary Completion Date November 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019)
  • Odds of autoimmune disease in SCAD cases compared to controls [ Time Frame: 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 3, 2019) 		SCAD recurrence [ Time Frame: Through study completion, or approximately 50 years (average age of study participants) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 3, 2019)
  • 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) ]
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
Official Title Determining the Association Between Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2020) 		114
Original Estimated Enrollment
 (submitted: May 3, 2019) 		600
Actual Study Completion Date November 10, 2020
Actual Primary Completion Date November 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03941184
Other Study ID Numbers 19-002489
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marysia Tweet, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account Mayo Clinic
Verification Date November 2020

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