CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography

NCT ID: NCT02074527

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Congenital Heart Disease; Cardiac Catheterization; Brazilian Electronic Registration; Catheterization Diagnostic or Therapeutic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Otavio Berwanger

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CAAE_08691912.8.1001.0060

Identifier Type: -

Identifier Source: org_study_id