Cerebrovascular Registry

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Mohammad Saadatnia, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03211091

First received: April 24, 2017

Last updated: July 5, 2017

Last verified: July 2017

History of Changes

Purpose

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
Cerebrovascular Disorders


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration:	2 Years
Official Title:	Prove/Cerebrovascular Registry

Further study details as provided by Mohammad Saadatnia, Isfahan University of Medical Sciences:

Primary Outcome Measures:

disability [ Time Frame: 3 months ]
the Barthel Index

Secondary Outcome Measures:

rehabilitation [ Time Frame: 3 months ]
Ashworth Scale
rehabilitation [ Time Frame: 12 months ]
Modified Ashworth Scale


Estimated Enrollment:	5000
Actual Study Start Date:	January 1, 2015
Estimated Study Completion Date:	January 1, 2020
Primary Completion Date:	January 10, 2017 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	15 Years to 90 Years (Child, Adult, Senior)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Mohammad Saadatnia, Professor Mohammad Saadatnia, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT03211091 History of Changes
Other Study ID Numbers:	Prove registry
Study First Received:	April 24, 2017
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
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 Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 11, 2017

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