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NCT00391378 · ClinicalTrials.gov registry record
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 363
- Enrollment target
NCT00391378 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 363 participants.
The verdict
NCT00391378 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 363 participants
- Enrollment target
Study Summary
Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. This study will identify risk factors that predict whether a person undergoing heart surgery will develop cerebral infarcts after surgery. It will also identify operative and inflammatory factors that may alter the risk, and will evaluate whether the small lesions are associated with cognitive decline at 6 months. People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart valve replacement, or combined CABG and valve replacement procedure are eligible for this study. Candidates must have no neurological or cognitive impairment before surgery. Participants will undergo standard medical and surgical treatment as determined by their physicians. In addition, they have the following procedures: * Medical and neurological evaluation before surgery and 24 and 48 hours after surgery. * Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery. * Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after surgery to quantify the response of their inflammatory system to surgery. * Neuropsychological examinations 30 days and 6 months after surgery. * In addition, patients who agree to enroll in a substudy that will explore whether differences in the genes coding for inflammatory molecules lead to a change in the risk of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2006-09-09 |
| Est. Completion | 2011-01-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00391378
The ClinicalTrials.gov registry entry for NCT00391378 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 363 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00391378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00391378 about?
NCT00391378 is a clinical study titled "Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)". Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. This study wil...
What is the current status of trial NCT00391378?
This trial is currently completed. The enrollment target is 363 participants. The study started on 2006-09-09. Estimated completion is 2011-01-03.
Who is sponsoring clinical trial NCT00391378?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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