Clinical trial NCT03398850: Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry
Official title: Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Dissection, Spontaneous
Keywords: spontaneous coronary artery dissection
acute coronary syndrome
coronary angiography
coronary tomography
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study population will be selected retrospectively and prospectively from several Brazilian tertiary Hospitals. Clinical data and coronary imaging will be imputed through electronic case report form (eCRF), which will be kept confidential at dedicated server at the Coordinator Center, Hospital Israelita Albert Einstein.

Brief summary: A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary manifestations due spontaneous coronary artery dissection
* Angiographic findings of SCAD in coronary angiogram or coronary tomography
* Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis.

Exclusion Criteria:

* Non-agreement for SCAD diagnosis
* Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.

Primary outcomes:
measure: Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection
timeFrame: 10 years
Secondary outcomes:
measure: Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.
timeFrame: 10 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: Sao Paulo
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Jamil Cade, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Adriano Caixeta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cade J, Mintz GS, Silva RM Filho, Caixeta A. Spontaneous coronary artery dissection and healing documented by optical coherence tomography. Einstein (Sao Paulo). 2016 Jul-Sep;14(3):435-436. doi: 10.1590/S1679-45082016AI3551. Epub 2016 Jul 4. No abstract available.
citation: Cade JR, Abizaid A, Caixeta A. Organized thrombus mimicking spontaneous coronary artery dissection. JACC Cardiovasc Interv. 2014 Dec;7(12):1458. doi: 10.1016/j.jcin.2014.08.004. Epub 2014 Nov 12. No abstract available.
citation: Saw J. Pregnancy-Associated Spontaneous Coronary Artery Dissection Represents an Exceptionally High-Risk Spontaneous Coronary Artery Dissection Cohort. Circ Cardiovasc Interv. 2017 Mar;10(3):e005119. doi: 10.1161/CIRCINTERVENTIONS.117.005119. No abstract available.
citation: Saw J. Coronary angiogram classification of spontaneous coronary artery dissection. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1115-22. doi: 10.1002/ccd.25293. Epub 2013 Dec 4.
citation: Saw J, Ricci D, Starovoytov A, Fox R, Buller CE. Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort. JACC Cardiovasc Interv. 2013 Jan;6(1):44-52. doi: 10.1016/j.jcin.2012.08.017. Epub 2012 Dec 19.
citation: Cade JR, Szarf G, de Siqueira ME, Chaves A, Andrea JC, Figueira HR, Gomes MM Jr, Freitas BP, Filgueiras Medeiros J, Dos Santos MR, Fiorotto WB, Daige A, Goncalves R, Cantarelli M, Alves CM, Echenique L, de Brito FS Jr, Perin MA, Born D, Hecht H, Caixeta A. Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients. Eur Heart J Cardiovasc Imaging. 2017 Jan;18(1):54-61. doi: 10.1093/ehjci/jew021. Epub 2016 Feb 28.