Cerebrovascular Registry

Cerebrovascular Disorders Clinical Trial

Official title:

Prove/Cerebrovascular Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03211091
• Other study ID #: Prove registry
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: July 5, 2017
• Start date: January 1, 2015
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2017
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: January 1, 2020
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients with acute Stroke (Hemorrhagic and Non Hemorrhagic)

Exclusion Criteria:

• patients who do not agree to continue cooperation

• patients with incomplete documents

Related Conditions & MeSH terms

• Cerebrovascular Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disability	the Barthel Index	3 months
Secondary	rehabilitation	Ashworth Scale	3 months
Secondary	rehabilitation	Modified Ashworth Scale	12 months