A Comparison of Hemorrhagic and Ischemic Strokes Among Bl... | NCT00642213

Studies
A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

NCT00642213

Sponsor

University of Cincinnati

Status

Active, not recruiting

Last Update Posted

Sep 24, 2024Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Ischemic Stroke
TIA
Hemorrhage

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NS030678	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1993

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 19, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2024

Last Update Posted Date

Sep 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brett Kissela, Principal Investigator, University of CincinnatiPrincipal Investigator

Lead Sponsor

University of CincinnatiOTHER

Collaborators

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

For calendar years 1993-94, 1999, 2005, 2010, 2015, and 2020 we will or have identified every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all regional hospitals in our region. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at more than 100 outpatient sites throughout five counties in Greater Cincinnati/Northern Kentucky. We plan to identify and abstract detailed information from the medical record for every potential case. These results will be compared with data from all stroke patients identified by similar methodology in all study periods.

In addition, we have interviewed 1500 ischemic stroke patients and/or their families in the study periods 1999-2010 to obtain detailed information including demographic information, functional outcome and quality of life, access to and type of rehabilitation therapy, social support, caregiver availability and health status, access to post-hospital care, health insurance status, current health status, medications, prior risk factors, and knowledge about stroke signs and symptoms. We also obtained genetic material via a blood sample for most of this cohort.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mRS	modified Rankin Scale	discharge or 30 days

Secondary Outcomes

Measure	Description	Time Frame
mortality	entire patient population checked for possible death record via NDI/CDC	1 year

Other Outcomes

Measure	Description	Time Frame
2020 Stroke population mRS	we will collect 3 months, 6 months, and 1 year mRS outcomes on the 2020 stroke patients	3 month, 6 month, and 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brett M Kissela, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati		Cincinnati	Ohio	45267-0525	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26415945	Derived	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.

ID	Term
D000083242	Ischemic Stroke
D006470	Hemorrhage
D020521	Stroke
D007511	Ischemia

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases