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The Post Stroke Preventive Trial (PREVENT). A RCT Nested in a Cohort Study
This study is currently recruiting participants.
Verified by Hvidovre University Hospital, June 2007
Sponsored by: Hvidovre University Hospital
Information provided by: Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00253097
  Purpose

Patients with a diagnosis of stroke or TIA, who are already included in the RIALTO-cohort study are asked to participate in a RCT after discharge from hospital.

Patients in the intervention group will receive four visits by a study nurse with the aim of controlling the patient's hypertension, reducing risk factors like tobacco smoking and obesity, and motivating the patient to physical activity and to a healthy diet.Patients in the control group will receive the usual treatment.

This study is aimed at testing the hypothesis, that

Primary outcome: the blood pressure lowering will be greater in the intervention group Secondary outcomes: the blood pressure will be lower in the intervention group and the number of patients who have stopped smoking will be greater in the intervention group The number of obese patients who have reduced their BMI will be greater in the intervention group The number of patients with a Rankin Scale<3 who are physically active for four hours a week will be greater in the intervention group Time to recurrent stroke, MI and death will be longer in the intervention group

Outcomes are measured by follow up visit one and two years after inclusion in the study

Expected Total Enrollment: 342 in the RCT, 1200 in the cohort

Study Start: 011205 (PREVENT) Study Completion: January 2009(PREVENT), September 2013 (RIALTO Cohort study)


Condition Intervention
Cerebrovascular Accident
Transient Ischemic Attack
Myocardial Infarction
Behavioral: blood pressure control

MedlinePlus related topics: Heart Attack Smoking Smoking and Youth Transient Ischemic Attack
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: The Post Stroke Preventive Trial (PREVENT) A Randomised Controlled Trial Nested in a Cohort (RIALTO) Study

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • blood pressure lowering at 12 and 24 months [ Time Frame: November 2006 - september 2009 ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: November 2006 - september 2009 ]
  • BMI [ Time Frame: November 2006 - september 2009 ]
  • Smoking status [ Time Frame: November 2006 - september 2009 ]
  • Level of physical activity [ Time Frame: November 2006 - september 2009 ]
  • Time to events:Stroke reccurrence, MI and death [ Time Frame: November 2006 - september 2009 ]
  • all assessed 12 and 24 months after inclusion in the study [ Time Frame: November 2006 - september 2009 ]

Estimated Enrollment: 342
Study Start Date: December 2005
Estimated Study Completion Date: September 2009
Detailed Description:

Stroke survivors are at risk of cerebrovascular and cardiovascular complications. In Denmark 25% of stroke admissions are caused by recurrent stroke or TIA. Little is known of the risk factors for recurrent stroke. This is being investigated in a cohort study (RIALTO) initiated in may 2004. The PREVENT study is aimed at studying the health behavior of stroke survivors as well as the effect of a preventive intervention aimed at risk factors associated with hypertension. Hypertension is the main risk factor for primary stroke and the one risk factor known to be associated with stroke recurrence.

Inclusion criteria: inclusion in the RIALTO-cohort, no severe cognitive deficits or dementia, no other life threatening disease.

Exclusion criteria: discharge to a nursing home

Participants (n=342) are randomised to either the intervention group (n=171) or the control group (n=171). Randomisation is performed by a computer-generated allocation schedule, with the randomisation sequence blocked from previewing. The analyser will be blinded from the allocation of the patients.

Baselinedata: Blood pressure, BMI and Rankin scale will be monitored few days prior to discharge.Blood pressure will be measured according to standards set by the Danish Society of hypertension.

Patients in the intervention group will receive a visit by a study nurse one, four, seven, and ten months after discharge. The aim of the visits are: controlling the patient's hypertension, reducing risk factors like tobacco smoking and obesity, motivating the patient to physical activity and to a healthy diet as well as compliance with pharmacological treatment of hypertension, diabetes, hypercholesterolemia and anti-thrombotic treatment.Patients in the control group will receive the usual treatment.

This study is aimed at testing the hypothesis, that

Primary outcome: the blood pressure lowering will be greater in the intervention group Secondary outcomes: the blood pressure will be lower in the intervention group and the number of patients who have stopped smoking will be greater in the intervention group The number of obese patients who have reduced their BMI will be greater in the intervention group The number of patients with a Rankin Scale<3 who are physically active for four hours a week will be greater in the intervention group Time to recurrent stroke, MI and death will be longer in the intervention group

Outcomes are measured by follow up visit one and two years after inclusion in the study. Hypertension is defined as a blood pressure > 140 mm Hg or > 90 mm Hg. The diagnosis of a recurrent stroke will be based on a CT og MR scan or on the clinical diagnosis made by a neurologist.MI should be confirmed by an ECG and by relevant biomarkers.

All participants will be followed up by register data for six years from inclusion as will all participants of the RIALTO cohort.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a diagnosis of stroke or TIA inclusion in the RIALTO cohort no severe cognitive deficits or dementia

Exclusion Criteria:

  • discharge to a nursing home
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253097

Contacts
Contact: Nete Hornnes, RN, MPH +4536322087 nete.hornnes@hvh.regionh.dk
Contact: Gudrun Boysen, MD, DMSc +4535312454 gudrun.boysen@bbh.regionh.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Nete Hornnes, RN,MPH     +4536322087     nete.hornnes@hvh.regionh.dk    
Contact: Gudrun Boysen, MD, MDSc     +4535312454     gudrun.boysen@bbh.regionh.dk    
Principal Investigator: Nete Hornnes, RH,MPH            
Frederiksb Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Nete Hornnes, RN, MPH     ++45 36322087     nete.hornnes@hvh.regionh.dk    
Contact: Gudrun Boysen, MD,DMSc, Professor     ++45 35312454     gb01@bbh.regionh.dk    
Principal Investigator: Nete Hornnes, RN, MPH            
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Nete Hornnes, RN, MPH Clinical Research Unit, Hvidovre Hospital
  More Information

Study ID Numbers: KFE 003
Study First Received: November 14, 2005
Last Updated: June 13, 2007
ClinicalTrials.gov Identifier: NCT00253097  
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
stroke recurrence
risk factors
health behavior
intervention
tertiary prevention

Study placed in the following topic categories:
Ischemic Attack, Transient
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Recurrence
Necrosis
Brain Ischemia
Brain Infarction
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009