Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

NCT03398850 | Recruiting DMC

• 1 other identifier: SCALIBUR Registry
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Dissection, Spontaneous

Keywords

spontaneous coronary artery dissection; acute coronary syndrome; coronary angiography; coronary tomography

Outcome Measures

Primary Outcomes (1)

• Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection

  All major adverse cardiac events will be collected

  10 years

Secondary Outcomes (1)

• Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 27383563 BACKGROUND

• 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.

  PMID: 25457056 BACKGROUND

• 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.

  PMID: 28302643 BACKGROUND

• 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.

  PMID: 24227590 BACKGROUND

• 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.

  PMID: 23266235 BACKGROUND

• 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.

  PMID: 26928981 RESULT

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jamil Cade, MD, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Adriano Caixeta, MD, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Pereira, RN

CONTACT

+551121519408; carolinap@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 16, 2018
• Study Start: January 1, 2000
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The first data will be available by 2019
• Access Criteria: All researchers will be have the data available upon requested

Locations

BR (1)