A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

NCT00642213 | Active Not Recruiting

• 2 other identifiers: UC IRB 2013-3959R01NS030678
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States. We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

Conditions

Ischemic Stroke; TIA; Hemorrhage

Keywords

stroke; ischemic; TIA; hemorrhage; incidence; case-fatality; risk factors; genetic

Outcome Measures

Primary Outcomes (1)

• mRS

  modified Rankin Scale

  discharge or 30 days

Secondary Outcomes (1)

• mortality

  1 year

Other Outcomes (1)

• 2020 Stroke population mRS

  3 month, 6 month, and 1 year

Study Arms (2)

ischemic stroke sample with DNA

We prospectively collected 450(1999), 502(2005), and 512(2010) ischemic stroke patients who agreed to participate and also most provided a sample for DNA. The cohort data consists of a baseline interview, medical record abstraction and various timeframes of followup interviews from 3 months to 3 years. See website (www.gcnkss.com for data forms)

stroke data from medical record review

The second part of the study is a retrospective medical record review of all potential ischemic strokes, TIAs, and Hemorrhagic strokes in our 5 county region that occurred in all study years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort:Ischemic stroke patient in 1999/2005/2010 that resides in the GCNK area. Retrospective cohorts: All stroke and TIA events occurring during the following study periods: 1993-94, 1999, 2005, 2010, 2015 and 2020. This group is ALL stroke patients of any age that resides in our 5 county region.

You may qualify if:

• ischemic stroke
• occurred in 1999/2005/2010
• \>18 years old
• resides in 5 county region

You may not qualify if:

• \<18 years old
• resides outside 5 county region
• inability to consent or have legal proxy consent

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0525, United States

Location

Related Publications (1)

• Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, Moomaw CJ, Woo D, Khatri P, Flaherty ML, Adeoye O, Ferioli S, Kissela B. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015 Sep 29;13:159. doi: 10.1186/s12955-015-0340-3.

  PMID: 26415945 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We have collected blood and/or buccal samples from an interviewed cohort during years 1999,2005, and 2010.

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhage; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brett M Kissela, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 24, 2008
• Study Start: July 1, 1993
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Current study data through 2015 is available via website. 2020 data will be available at a future date.
• Access Criteria: please see website below

Locations

US (1)