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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04222608
Other study ID # BRAvAdO
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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