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NCT00391378
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
trial in Stroke in 363 participants. Completed in 3 January 2011.
Quick facts
| Lead sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 363 |
| Start date | 9 September 2006 |
| Estimated completion | 3 January 2011 |
| Sites | 1 location across United States |
Conditions studied
- Stroke — all drugs for Stroke →
- Cognitive Symptoms — all drugs for Cognitive Symptoms →
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Who can join
18 and older, any sex, with Stroke or Cognitive Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00391378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institute of Neurological Disorders and Stroke (NINDS) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00391378 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS)
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00391378.
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