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Cerebrovascular Registry

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ClinicalTrials.gov Identifier: NCT03211091
Recruitment Status : Unknown
Verified July 2017 by Mohammad Saadatnia, Isfahan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammad Saadatnia, Isfahan University of Medical Sciences

Brief Summary:
Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up for 28 days, starting in 2015 in PROVE Registry

Condition or disease
Cerebrovascular Disorders

Detailed Description:

PROVE program started in 2015, the registration of stroke continued but followed the WHO Stepwise method instead of WHO/MONICA .Patients are followed up for two years. The corresponding questionnaire covered the patients' demographic data, medical history upon hospital admission, history of comorbidities, medications used prior to the treatment, history of drug abuse, heart and brain imaging, history of blood tests and blood diseases, hospital treatments received, hospitalization complications, medications prescribed at the time of discharge, discharge status and the definite diagnosis of type of stroke according to CT or MRI.

The patients were followed-up over the phone or in person from the 1st, 3rd and 12th months to two years. The patients' disabilities were measured using the Barthel Index and the Modified Rankin Scale (MRS). The reliability and validity of these two questionnaires have already been investigated in Persian. In addition, secondary prevention measures, rehabilitation status and the incidence of new cardiovascular events were also examined in the follow-up. The stroke registration personnel received an initial training of three two-hour sessions and monthly one-hour retraining sessions. They visited the archives of various hospitals on a daily basis and registered the data contained in the records

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prove/Cerebrovascular Registry
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : January 10, 2017
Estimated Study Completion Date : January 1, 2020



Primary Outcome Measures :
  1. disability [ Time Frame: 3 months ]
    the Barthel Index


Secondary Outcome Measures :
  1. rehabilitation [ Time Frame: 3 months ]
    Ashworth Scale

  2. rehabilitation [ Time Frame: 12 months ]
    Modified Ashworth Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with stroke or stroke history
Criteria

Inclusion Criteria:

* patients with acute Stroke (Hemorrhagic and Non Hemorrhagic)

Exclusion Criteria:

  • patients who do not agree to continue cooperation
  • patients with incomplete documents
Additional Information:

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Responsible Party: Mohammad Saadatnia, Professor Mohammad Saadatnia, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03211091    
Other Study ID Numbers: Prove registry
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases