CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography

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.

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Key information

Conditions

Congenital Heart Disease Brazilian Electronic Registration Cardiac Catheterization Cardiovascular Abnormalities Cardiovascular Diseases Catheterization Diagnostic or Therapeutic Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Otavio Berwanger

São Paulo, 04005-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Occurrence of serious complications of cardiac catheterization in congenital heart

Time frame: December 2014

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

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: CHAIN

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Feb 28, 2014
Registry last updated: Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed