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NCT00549796 · ClinicalTrials.gov registry record · NA
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 18,876
- Enrollment target
NCT00549796: Completed NA study, sponsored by Johns Hopkins University.
NCT00549796 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 18,876 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00549796, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 18,876 participants
- Enrollment target
Study Summary
Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty can cause injury to the heart artery that might require open heart surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart surgery will be needed is very small. Nevertheless, without more research, many state Departments of Health and all national heart organizations do not want to change the requirement for having on-site open heart surgery wherever angioplasty is performed. Some States already allow this; and European heart organizations already allow it, as well. This study is designed to determine whether the safety and benefits of angioplasty are the same at hospitals that perform angioplasty either with or without open heart surgery backup. Patient who enter the study have a heart catheterization at a hospital without a heart surgery program. If they need angioplasty, then they are randomized to either stay at the hospital without heart surgery for their angioplasty or to be transferred for the procedure to a hospital with heart surgery. For every four patients, three stay at the hospital without heart surgery and one is transferred. The study is designed to show that there is no detectable difference between the safety and benefits of the procedure at the two types of hospital (with and without heart surgery). The cost of the procedure at the two hospital types is also compared.
Interventions
- OTHER Percutaneous coronary intervention (PCI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18,876 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549796
The ClinicalTrials.gov registry entry for NCT00549796 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18,876 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Percutaneous coronary intervention (PCI) is the first listed.
NCT00549796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00549796 about?
NCT00549796 is a clinical study titled "Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery". Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty ...
What is the current status of trial NCT00549796?
This trial is currently completed. It is a NA study. The enrollment target is 18,876 participants. The study started on 2006-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00549796?
The interventions under investigation include: Percutaneous coronary intervention (PCI) (OTHER).
Who is sponsoring clinical trial NCT00549796?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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