The BRAvAdO Registry (BRAvAdO)

January 6, 2020 updated by: University of Sao Paulo General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Carlos M Campos
        • Contact:
        • Principal Investigator:
          • Ludhmila A Hajjar, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients with Acute Coronary Syndrome (ACS)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 30 days
Composite endpoint of All-cause Death, Myocardial Infarction, Stroke and Myocardial Revascularization
30 days
Total Atherosclerotic burden and lesion complexity on angiography
Time Frame: 30 days
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
Incidence of Major Bleeding
Time Frame: 30 days
Requiring a transfusion of ≥2 U PRBCs Resulting in a decrease in hematocrit of ≥10% Occurring intracerebrally Resulting in stroke or death
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Instituto de Cardiologia do Rio Grande do Sul
InCor Heart Institute
Instituto do Cancer do Estado de São Paulo
Beneficência Portuguesa de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAvAdO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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