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NCT02338947 · ClinicalTrials.gov registry record · NA
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
A NA study of Coronary Artery Disease and Frail Elderly, sponsored by University of Sao Paulo General Hospital.
- Active
- Registry status
- NA
- Development phase
- 440
- Enrollment target
- 7
- Study locations
NCT02338947: Active NA study of Coronary Artery Disease and Frail Elderly, sponsored by University of Sao Paulo General Hospital.
NCT02338947 is a NA study of Coronary Artery Disease and Frail Elderly that is active but no longer recruiting, run by University of Sao Paulo General Hospital. The registered enrollment target is 440 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (66% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338947, a NA study of Coronary Artery Disease and Frail Elderly, is active but no longer recruiting, sponsored by University of Sao Paulo General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 440 participants
- Enrollment target
- 7
- Study locations
Study Summary
Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.
Primary Outcome
This composite outcome comprises: all cause death, acute myocardial infarction, stroke, renal failure, acute respiratory distress syndrome and bleeding reoperation
Conditions Studied
Interventions
- OTHER Off-pump coronary-artery bypass grafting
- OTHER On-pump coronary-artery bypass grafting
Study Locations (7)
São Paulo
- Beneficência Portuguesa de São Paulo - São Paulo
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo - São Paulo
Georgia
- Emory University School of Medicine - Atlanta
Ceará
- Hospital de Messejana - Fortaleza
Minas Gerais
- Hospital das Clínicas Samuel Libânio - Pouso Alegre
Paraíba
- Hospital Alberto Urquiza Wanderley - João Pessoa
Rio de Janeiro
- Instituto Nacional de Cardiologia de Laranjeiras - Rio de Janeiro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT02338947 still lists
NCT02338947 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Off-pump coronary-artery bypass grafting is the first listed.
NCT02338947 lists 7 locations in 6 states (São Paulo, Georgia, Ceará).
Frequently Asked Questions
What is clinical trial NCT02338947 about?
NCT02338947 is a clinical study titled "Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients". Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surger...
What is the current status of trial NCT02338947?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 440 participants. The study started on 2019-01-01. Estimated completion is 2025-12-31.
What conditions does trial NCT02338947 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Frail Elderly.
What interventions are being tested in trial NCT02338947?
The interventions under investigation include: Off-pump coronary-artery bypass grafting (OTHER), On-pump coronary-artery bypass grafting (OTHER).
Who is sponsoring clinical trial NCT02338947?
This trial is sponsored by University of Sao Paulo General Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02338947 being conducted?
This trial has 7 study locations across Georgia, Ceará, Minas Gerais, Paraíba, Rio de Janeiro. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02338947's enrollment target sits among peer trials
440 82nd of 219 higher than 138 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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