Clincosm LogoSign in Get a demo

Cerebrovascular Registry

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT03211091
Collaborator
(none)
5,000
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prove/Cerebrovascular Registry
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jan 10, 2017
    Anticipated Study Completion Date :
    Jan 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. disability [3 months]

      the Barthel Index

    Secondary Outcome Measures

    1. rehabilitation [3 months]

      Ashworth Scale

    2. rehabilitation [12 months]

      Modified Ashworth Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with acute Stroke (Hemorrhagic and Non Hemorrhagic)
    Exclusion Criteria:

    • patients who do not agree to continue cooperation

    • patients with incomplete documents

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad Saadatnia, Professor Mohammad Saadatnia, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03211091
    Other Study ID Numbers:
    • Prove registry
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    Jul 7, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cerebrovascular Disorders

    Study Results

    No Results Posted as of Jul 7, 2017