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NCT02074527 Clinical Trial

CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography

Congenital Heart Disease Clinical Trial

— CHAIN  

Official title:
Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02074527
Other study ID # CAAE_08691912.8.1001.0060
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date December 2015

Study information
Verified date February 2014
Source Hospital do Coracao
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.

Description:

Patients admitted in the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Participants release the data in (e-CRF) electronics system. Sample: 2000 records.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day and older
Eligibility Inclusion Criteria: - Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Exclusion Criteria: - Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Otavio Berwanger Sao Paulo

Sponsors (2)
Lead Sponsor Collaborator
Hospital do Coracao Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of serious complications of cardiac catheterization in congenital heart Occurrence of serious complications of cardiac catheterization in congenital heart procedure-related (occurring within 7 days after the procedure or until hospital discharge, whichever occurs first, and following 30 days), such as embolization of the prosthesis, cardiac arrhythmias, trauma vascular intracardiac injury, death, etc December 2014
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