Congenital Heart DiseaseCHAINNCT02074527
CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography
An observational study of Congenital Heart Disease and Cardiac Catheterization, run by Hospital do Coracao at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Cardiac Catheterization, Brazilian Electronic Registration
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Dec 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.
Who may be able to join
- Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.
Who cannot join
- Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 0 _ 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.
Read the 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
- Keywords
- congenital heart disease, cardiac catheterization, brazilian electronic registration
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074527
- Sponsor's protocol ID
- CAAE_08691912.8.1001.0060
- Acronym
- CHAIN
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography
- ClinicalTrials.gov ID
- NCT02074527
- Acronym / sponsor ID
- CHAIN / CAAE_08691912.8.1001.0060
- Conditions
- Congenital Heart Disease, Cardiac Catheterization, Brazilian Electronic Registration, Catheterization Diagnostic or Therapeutic
- Keywords
- congenital heart disease, cardiac catheterization, brazilian electronic registration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.
Key inclusion criteria (1 listed)
- Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.
Key exclusion criteria (1 listed)
- Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Cardiac Catheterization, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of serious complications of cardiac catheterization in congenital heart (time frame: December 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.