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Home > "P" Clinical Trials Conditions > Predictors of Recurrent Stroke in the PROGRESS Study  Predictors of Recurrent Stroke in the PROGRESS Study
Predictors of Recurrent Stroke in the PROGRESS Study
For Condition: Hypertension,Cerebrovascular Accident,Cardiovascular Diseases,Cerebrovascular Disorders
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To investigate mechanisms of recurrent stroke.
Details: BACKGROUND: There is an urgent need to design more effective stroke prevention strategies. Previous prevention strategies including blood pressure control and anti-platelet therapy resulted in only a 43% reduction in stroke risk in a multi-center study, PROGRESS. Other proposed potentially modifiable mechanisms that mediate endothelial cell injury and activation leading to accelerated atherosclerosis include dyslipidemia, oxidative stress, endothelial dysfunction, inflammation, and renin-angiotensin system (RAS) activation are candidate strategies. Plasma markers of these various proposed mechanisms will be studied to see if they predicted recurrent stroke. Since strokes kill 5 million people each year, at least one third of the 15 million others who sustain a non-fatal stroke suffer permanent disability, and those who have a transient ischemic attack (TIA) are also likely to have a recurrent event, identifying potentially modifiable risk factors would significantly reduce morbidity and mortality due to strokes worldwide. The study is based on plasma samples taken on enrollment from a subset of the 6,105 subjects in the Perindopril Protection Against Recurrent Stroke Study (PROGRESS). The PROGRESS was an international, randomized, double-blind controlled study of a perindopril-based blood pressure lowering regimen among individuals with stroke or transient ischemic attack within the previous five years. Coordination and monitoring for PROGRESS were maintained through two international coordinating centers, one in Sydney, Australia and the other in Auckland and through seven regional coordinating centers in Beijing, Glasgow, Melbourne, Milan, Osaka, Paris and Uppsala. There were 172 local clinical centers distributed through 10 countries: Australia, Belgium, China, France, Ireland, Italy, Japan, New Zealand, Sweden and the United Kingdom. The study is in response to a Request for Applications entitled "NHLBI Innovative Research Grant Program" released in July, 2001. The purpose of the initiative is to support new approaches to heart, lung, and blood diseases and sleep disorders that use existing data sets or existing biological specimen collections whether obtained through National Heart, Lung, and Blood Institute support or not. DESIGN NARRATIVE: This is a nested case-control study. From the plasma samples obtained from 6,105 subjects enrolled in the PROGRESS study, 727 are from subjects who experienced recurrent stroke during the study. The cases will be the 325 from this 727 from whom plasma samples were collected more than one month after the qualifying event and frozen at -80°C within 24 hours. Each case will be matched to two control subjects who had no cardiovascular event.The data will be related to clinical markers of cardiovascular risk on enrollment. The study will determine which of these plasma markers provides an independent measure of risk of recurrent stroke. In addition, the study will determine those plasma markers that provide an independent measure of reduction in risk of recurrent stroke by perindopril-based antihypertensive therapy, thereby providing a means to identify those subjects most likely to benefit from such therapy, and conversely, those subjects in whom alternative preventative strategies are required. In addition, plasma markers that predict risk of recurrent stroke may indicate novel therapies to prevent this condition. Specific aims include identifying whether nuclear magnetic resonance-determined lipoprotein profiles, and plasma levels of homocysteine, protein carbonyls, chlorotyrosine, soluble vascular cell adhesion molecule (sVCAM-1), C-reactive peptide (CRP), active renin, and the amino-terminal pro-B-type natriuretic peptide (NT-proBNP) predict recurrent stroke in PROGRESS study participants and whether these measures predict benefit from perindopril-based antihypertensive therapy.
Eligibility:
Study Type: Observational, Natural History, Case Control, Retrospective Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DuncanCampbell, , St. Vincent's Institute of Medical Research
Additional Information:
Study ID Numbers: 1201;
Study Start Date: September 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049894
Other Hypertension Studies:
1. Hypertension Detection and Follow-up Program (HDFP)
2. Adolescent Blood Pressure Variation and Ventricular Mass
3. Epidemiology of Coronary Calcification in the Elderly
4. Physical Activity and Cardiovascular Risk in Black Girls
5. Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
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Predictors of Recurrent Stroke in the PROGRESS Study
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