Coronary Artery Dissection, Spontaneous Clinical Trial
— SCALIBUROfficial title:
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelita Albert Einstein | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
Brazil,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02008786 -
Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD
|
Phase 4 |