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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03398850
Other study ID # SCALIBUR Registry
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Terminated NCT02008786 - Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD Phase 4