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

Spontaneous Coronary Artery Dissection Clinical Trial

— SCAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01429727
• Other study ID #: 11-001852
• Status: Recruiting
• Start date: July 2011
• Est. completion date: December 2030

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Susan Milbrandt
• Phone: 507-266-3180
• Email: mayoscad[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event. This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

Description:

Spontaneous Coronary Artery Dissection (SCAD) is a relatively rare and poorly understood condition that has been reported to affect more women than men. The coronary arteries consist of three layers, and dissection occurs when two of these layers separate, enabling blood to flow into the space between the layers. As the blood accumulates, this can cause obstruction to normal blood flow within the heart, leading to chest pain, heart attack and even sudden death. The medical community has much to learn about treatment and prevention of this potentially fatal cardiovascular event. Mayo Clinic is conducting two studies of SCAD. This study consists of building a database/registry of patients with SCAD (whether they have been patients at Mayo Clinic or not) to identify patterns of SCAD incidence, causes and associations that could guide future research. With participant consent, Mayo Clinic staff will request a copy of the original coronary angiogram when SCAD was diagnosed to confirm the diagnosis and determine eligibility. If eligible, study coordinators will contact the participant to provide more information about the studies and request a signed informed consent document.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women able to give informed consent
• Diagnosis of one or more episodes of spontaneous coronary artery dissection (SCAD)
• SCAD in women who are pregnant or within 12 months postpartum at the time of SCAD
• SCAD in individuals who self-identify as a member of a racial or ethnic group that is currently underrepresented in the registry. This would include anyone who identifies as: Black/African American, Asian, American Indian, or Alaska Native, Native Hawaiian, or Other Pacific Islander, and any race with Hispanic ethnicity
• SCAD in a man
• SCAD in persons younger than 30 years of age
• SCAD within the past 2 weeks (acute)
• SCAD patient enrolling into any other Mayo Clinic SCAD Research Study
• SCAD in individuals who have a relative that has had a SCAD event

Exclusion Criteria:

• Lack of angiographic confirmation of SCAD
• Iatrogenic dissection or an alternate diagnosis

Related Conditions & MeSH terms

• Aortic Dissection
• Coronary Vessel Anomalies
• SCAD
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (37)

Adlam D, Olson TM, Combaret N, Kovacic JC, Iismaa SE, Al-Hussaini A, O'Byrne MM, Bouajila S, Georges A, Mishra K, Braund PS, d'Escamard V, Huang S, Margaritis M, Nelson CP, de Andrade M, Kadian-Dodov D, Welch CA, Mazurkiewicz S, Jeunemaitre X; DISCO Consortium; Wong CMY, Giannoulatou E, Sweeting M, Muller D, Wood A, McGrath-Cadell L, Fatkin D, Dunwoodie SL, Harvey R, Holloway C, Empana JP, Jouven X; CARDIoGRAMPlusC4D Study Group; Olin JW, Gulati R, Tweet MS, Hayes SN, Samani NJ, Graham RM, Motreff P, Bouatia-Naji N. Association of the PHACTR1/EDN1 Genetic Locus With Spontaneous Coronary Artery Dissection. J Am Coll Cardiol. 2019 Jan 8;73(1):58-66. doi: 10.1016/j.jacc.2018.09.085. — View Citation

Adlam D, Tweet MS, Gulati R, Kotecha D, Rao P, Moss AJ, Hayes SN. Spontaneous Coronary Artery Dissection: Pitfalls of Angiographic Diagnosis and an Approach to Ambiguous Cases. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1743-1756. doi: 10.1016/j.jcin.2021.06.027. — View Citation

Benson JC, Lehman VT, Verdoorn JT, Shlapak DP, Hayes SN, Tweet MS. Prevalence of Cervical Artery Abnormalities on CTA in Patients with Spontaneous Coronary Artery Dissection: Fibromuscular Dysplasia, Dissection, Aneurysm, and Tortuosity. AJNR Am J Neuroradiol. 2021 Aug;42(8):1497-1502. doi: 10.3174/ajnr.A7151. Epub 2021 May 13. — View Citation

Codsi E, Tweet MS, Rose CH, Arendt KW, Best PJM, Hayes SN. Spontaneous Coronary Artery Dissection in Pregnancy: What Every Obstetrician Should Know. Obstet Gynecol. 2016 Oct;128(4):731-738. doi: 10.1097/AOG.0000000000001630. — View Citation

Eleid MF, Guddeti RR, Tweet MS, Lerman A, Singh M, Best PJ, Vrtiska TJ, Prasad M, Rihal CS, Hayes SN, Gulati R. Coronary artery tortuosity in spontaneous coronary artery dissection: angiographic characteristics and clinical implications. Circ Cardiovasc Interv. 2014 Oct;7(5):656-62. doi: 10.1161/CIRCINTERVENTIONS.114.001676. Epub 2014 Aug 19. — View Citation

Eleid MF, Tweet MS, Young PM, Williamson E, Hayes SN, Gulati R. Spontaneous coronary artery dissection: challenges of coronary computed tomography angiography. Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):609-613. doi: 10.1177/2048872616687098. Epub 2017 Jan 31. — View Citation

Goel K, Tweet M, Olson TM, Maleszewski JJ, Gulati R, Hayes SN. Familial spontaneous coronary artery dissection: evidence for genetic susceptibility. JAMA Intern Med. 2015 May;175(5):821-6. doi: 10.1001/jamainternmed.2014.8307. — View Citation

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. — View Citation

Hayes SN, Tweet MS, Adlam D, Kim ESH, Gulati R, Price JE, Rose CH. Spontaneous Coronary Artery Dissection: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Aug 25;76(8):961-984. doi: 10.1016/j.jacc.2020.05.084. — View Citation

Hayes SN. Spontaneous coronary artery dissection (SCAD): new insights into this not-so-rare condition. Tex Heart Inst J. 2014 Jun 1;41(3):295-8. doi: 10.14503/THIJ-14-4089. eCollection 2014 Jun. No abstract available. — View Citation

Henkin S, Negrotto SM, Tweet MS, Kirmani S, Deyle DR, Gulati R, Olson TM, Hayes SN. Spontaneous coronary artery dissection and its association with heritable connective tissue disorders. Heart. 2016 Jun 1;102(11):876-81. doi: 10.1136/heartjnl-2015-308645. Epub 2016 Feb 10. — View Citation

Johnson AK, Hayes SN, Sawchuk C, Johnson MP, Best PJ, Gulati R, Tweet MS. Analysis of Posttraumatic Stress Disorder, Depression, Anxiety, and Resiliency Within the Unique Population of Spontaneous Coronary Artery Dissection Survivors. J Am Heart Assoc. 2020 May 5;9(9):e014372. doi: 10.1161/JAHA.119.014372. Epub 2020 Apr 28. — View Citation

Johnson AK, Tweet MS, Rouleau SG, Sadosty AT, Hayes SN, Raukar NP. The presentation of spontaneous coronary artery dissection in the emergency department: Signs and symptoms in an unsuspecting population. Acad Emerg Med. 2022 Apr;29(4):423-428. doi: 10.1111/acem.14426. Epub 2021 Dec 26. — View Citation

Kok SN, Hayes SN, Cutrer FM, Raphael CE, Gulati R, Best PJM, Tweet MS. Prevalence and Clinical Factors of Migraine in Patients With Spontaneous Coronary Artery Dissection. J Am Heart Assoc. 2018 Dec 18;7(24):e010140. doi: 10.1161/JAHA.118.010140. — View Citation

Krittanawong C, Tweet MS, Hayes SE, Bowman MJ, Gulati R, Squires RW, Hayes SN. Usefulness of Cardiac Rehabilitation After Spontaneous Coronary Artery Dissection. Am J Cardiol. 2016 May 15;117(10):1604-1609. doi: 10.1016/j.amjcard.2016.02.034. Epub 2016 Mar 2. — View Citation

Kronzer VL, Tarabochia AD, Lobo Romero AS, Tan NY, O'Byrne TJ, Crowson CS, Turley TN, Myasoedova E, Davis JM 3rd, Raphael CE, Gulati R, Hayes SN, Tweet MS. Lack of Association of Spontaneous Coronary Artery Dissection With Autoimmune Disease. J Am Coll Cardiol. 2020 Nov 10;76(19):2226-2234. doi: 10.1016/j.jacc.2020.09.533. — View Citation

Liang JJ, Prasad M, Tweet MS, Hayes SN, Gulati R, Breen JF, Leng S, Vrtiska TJ. A novel application of CT angiography to detect extracoronary vascular abnormalities in patients with spontaneous coronary artery dissection. J Cardiovasc Comput Tomogr. 2014 May-Jun;8(3):189-97. doi: 10.1016/j.jcct.2014.02.001. Epub 2014 Apr 4. — View Citation

Lindor RA, Tweet MS, Goyal KA, Lohse CM, Gulati R, Hayes SN, Sadosty AT. Emergency Department Presentation of Patients with Spontaneous Coronary Artery Dissection. J Emerg Med. 2017 Mar;52(3):286-291. doi: 10.1016/j.jemermed.2016.09.005. Epub 2016 Oct 8. — View Citation

Prasad M, Tweet MS, Hayes SN, Leng S, Liang JJ, Eleid MF, Gulati R, Vrtiska TJ. Prevalence of extracoronary vascular abnormalities and fibromuscular dysplasia in patients with spontaneous coronary artery dissection. Am J Cardiol. 2015 Jun 15;115(12):1672-7. doi: 10.1016/j.amjcard.2015.03.011. Epub 2015 Mar 23. — View Citation

Silber TC, Tweet MS, Bowman MJ, Hayes SN, Squires RW. Cardiac rehabilitation after spontaneous coronary artery dissection. J Cardiopulm Rehabil Prev. 2015 Sep-Oct;35(5):328-33. doi: 10.1097/HCR.0000000000000111. — View Citation

Tan NY, Hayes SN, Young PM, Gulati R, Tweet MS. Usefulness of Cardiac Magnetic Resonance Imaging in Patients With Acute Spontaneous Coronary Artery Dissection. Am J Cardiol. 2018 Nov 15;122(10):1624-1629. doi: 10.1016/j.amjcard.2018.07.043. Epub 2018 Aug 20. — View Citation

Tarabochia AD, Tan NY, Lewis BR, Slusser JP, Hayes SN, Best PJM, Gulati R, Deshmukh AJ, Tweet MS. Association of Spontaneous Coronary Artery Dissection With Atrial Arrhythmias. Am J Cardiol. 2023 Jan 1;186:203-208. doi: 10.1016/j.amjcard.2022.09.032. Epub 2022 Oct 31. — View Citation

Turley TN, Kosel ML, Bamlet WR, Gulati R, Hayes SN, Tweet MS, Olson TM. Susceptibility Locus for Pregnancy-Associated Spontaneous Coronary Artery Dissection. Circ Genom Precis Med. 2021 Aug;14(4):e003398. doi: 10.1161/CIRCGEN.121.003398. Epub 2021 Aug 13. No abstract available. — View Citation

Turley TN, O'Byrne MM, Kosel ML, de Andrade M, Gulati R, Hayes SN, Tweet MS, Olson TM. Identification of Susceptibility Loci for Spontaneous Coronary Artery Dissection. JAMA Cardiol. 2020 Aug 1;5(8):929-938. doi: 10.1001/jamacardio.2020.0872. — View Citation

Turley TN, Theis JL, Sundsbak RS, Evans JM, O'Byrne MM, Gulati R, Tweet MS, Hayes SN, Olson TM. Rare Missense Variants in TLN1 Are Associated With Familial and Sporadic Spontaneous Coronary Artery Dissection. Circ Genom Precis Med. 2019 Apr;12(4):e002437. doi: 10.1161/CIRCGEN.118.002437. Epub 2019 Mar 19. — View Citation

Tweet MS, Akhtar NJ, Hayes SN, Best PJ, Gulati R, Araoz PA. Spontaneous coronary artery dissection: Acute findings on coronary computed tomography angiography. Eur Heart J Acute Cardiovasc Care. 2019 Aug;8(5):467-475. doi: 10.1177/2048872617753799. Epub 2018 Jan 29. — View Citation

Tweet MS, Codsi E, Best PJM, Gulati R, Rose CH, Hayes SN. Menstrual Chest Pain in Women With History of Spontaneous Coronary Artery Dissection. J Am Coll Cardiol. 2017 Oct 31;70(18):2308-2309. doi: 10.1016/j.jacc.2017.08.071. No abstract available. — View Citation

Tweet MS, Gulati R, Aase LA, Hayes SN. Spontaneous coronary artery dissection: a disease-specific, social networking community-initiated study. Mayo Clin Proc. 2011 Sep;86(9):845-50. doi: 10.4065/mcp.2011.0312. — View Citation

Tweet MS, Gulati R, Hayes SN. Spontaneous Coronary Artery Dissection. Curr Cardiol Rep. 2016 Jul;18(7):60. doi: 10.1007/s11886-016-0737-6. — View Citation

Tweet MS, Gulati R, Hayes SN. What Clinicians Should Know Alphabout Spontaneous Coronary Artery Dissection. Mayo Clin Proc. 2015 Aug;90(8):1125-30. doi: 10.1016/j.mayocp.2015.05.010. — View Citation

Tweet MS, Gulati R, Williamson EE, Vrtiska TJ, Hayes SN. Multimodality Imaging for Spontaneous Coronary Artery Dissection in Women. JACC Cardiovasc Imaging. 2016 Apr;9(4):436-50. doi: 10.1016/j.jcmg.2016.01.009. — View Citation

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. — View Citation

Tweet MS, Hayes SN, Gulati R, Rose CH, Best PJ. Pregnancy after spontaneous coronary artery dissection: a case series. Ann Intern Med. 2015 Apr 21;162(8):598-600. doi: 10.7326/L14-0446. No abstract available. — View Citation

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. — View Citation

Tweet MS, Young KA, Best PJM, Hyun M, Gulati R, Rose CH, Hayes SN. Association of Pregnancy With Recurrence of Spontaneous Coronary Artery Dissection Among Women With Prior Coronary Artery Dissection. JAMA Netw Open. 2020 Sep 1;3(9):e2018170. doi: 10.1001/jamanetworkopen.2020.18170. — View Citation

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. — View Citation

Waterbury TM, Tweet MS, Hayes SN, Prasad A, Lerman A, Gulati R. Coronary endothelial function and spontaneous coronary artery dissection. Eur Heart J Acute Cardiovasc Care. 2020 Feb;9(1):90-95. doi: 10.1177/2048872618795255. Epub 2018 Aug 20. — View Citation

* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive Data	Obtain data regarding SCAD related risk factors, presenting characteristics, treatments and long term outcomes.	Continuous time frame following index event for 2-10 years from study contact date.
Secondary	Physical Health Update	Record update on patient's current physical health and any relevant health events that may have occurred since the initial SCAD event.	Continuous time frame following index event for 2-10 years from study contact date.
Secondary	Mental Health Update	Record update on patient's current mental health status since the initial SCAD event.	Continuous time frame following index event for 2-10 years from study contact date.

External Links

•   Information for patients about spontaneous coronary artery dissection
•   Mayo Clinic Clinical Trials
•   Mayo Clinic SCAD Research Page