The BRAvAdO Registry

Oncology Clinical Trial

— BRAvAdO  

Official title:

BRAzilian Registry of Acute Coronary Syndrome in Oncologic Patients - The BRAvAdO Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222608
• Other study ID #: BRAvAdO
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Definitive cancer diagnosis - biopsy

• Acute Coronary Syndrome - requiring urgent invasive risk stratification

Exclusion Criteria:

• KPS < 60 , ECOG >/ 3

• Life expectancy less 24hs

• End of Life Care

• Lack of consistent record data

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• Neoplasms
• Oncology
• Syndrome

Locations

Country	Name	City	State
Brazil	Carlos M Campos	São Paulo

Sponsors (5)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Beneficência Portuguesa de São Paulo, InCor Heart Institute, Instituto de Cardiologia do Rio Grande do Sul, Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Composite endpoint of All-cause Death, Myocardial Infarction, Stroke and Myocardial Revascularization	30 days
Primary	Total Atherosclerotic burden and lesion complexity on angiography	The number and location of coronary lesions with obstructions greater than 50% were recorded. Each lesion was classified based on Ambrose's, Goldstein complexity, Leaman and SYNTAX scores.	30 days
Primary	Incidence of Major Bleeding	Requiring a transfusion of =2 U PRBCs Resulting in a decrease in hematocrit of =10% Occurring intracerebrally Resulting in stroke or death	30 days