Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

Coronary Artery Dissection, Spontaneous Clinical Trial

— SCALIBUR  

Official title:

Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398850
• Other study ID #: SCALIBUR Registry
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2017
• Last updated: January 12, 2018
• Start date: January 1, 2000
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2018
• Source: Hospital Israelita Albert Einstein
• Contact: Carolina Pereira, RN
• Phone: +551121519408
• Email: carolinap[@]einstein.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Coronary Artery Dissection, Spontaneous
• Coronary Vessel Anomalies
• Vascular Diseases

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & 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. English, Portuguese. — View 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. — View Citation

Cade JR, Szarf G, de Siqueira ME, Chaves Á, Andréa JC, Figueira HR, Gomes MM Jr, Freitas BP, Filgueiras Medeiros J, Dos Santos MR, Fiorotto WB, Daige A, Gonçalves R, Cantarelli M, Alves CM, Echenique L, de Brito FS Jr, Perin MA, Born D, Hecht H, Caixeta A — View 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. — View 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. Review. — View 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). pii: e005119. doi: 10.1161/CIRCINTERVENTIONS.117.005119. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection	All major adverse cardiac events will be collected	10 years
Secondary	Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.	Multimodality intravascular imaging will be recorded	10 years