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CompletedNCT03941184Updated Nov 23, 2020

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

An observational study in SCAD, Addison Disease and Ankylosing Spondylitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2020-11-23.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
114
Ages
18 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Addison Disease

36 studies on the registry are indexed under Addison Disease; 9 are open to participants now.

This study's enrollment of 114 is above the median of 91 across 10 observational studies indexed under Addison Disease.

Browse Addison Disease studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
114 participants (actual)
Patient registry
No

Groups and 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.

06

What researchers measure

Primary outcomes

  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 outcomes

  1. SCAD recurrence

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

Other outcomes

  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

    using the Rochester Epidemiology Project Rheumatoid Arthritis cohort

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

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

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. PubMed 22800851 ↗
  • McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006 Aug;3(8):e297. doi: 10.1371/journal.pmed.0030297. PubMed 16942393 ↗
  • 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. PubMed 23159830 ↗
  • 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. PubMed 29493808 ↗
  • 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. PubMed 29472380 ↗
  • 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. PubMed 29481627 ↗
  • 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. PubMed 30354594 ↗
  • 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. PubMed 25406203 ↗
  • 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. PubMed 28728686 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 1995 to primary completion in Nov 2020, 310 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2019
First posted
May 7, 2019
StartActual
Jan 1, 1995
Primary completionActual
Nov 10, 2020
CompletionActual
Nov 10, 2020
Last update
Nov 23, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03941184
Lead sponsor
Mayo Clinic
Responsible party
Marysia Tweet (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 7, 2019
Start date
Jan 1, 1995
Primary completion
Nov 10, 2020
Completion
Nov 10, 2020
Last update
Nov 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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