Stroke

The Caring for Adults Recovering from Stroke (CARES)

CARES project looks at what happens to families after an older adult experiences a stroke.  African American and White family caregivers of stroke survivors are being recruited from across the country to participate in a longitudinal observational study of stroke burden on families.  This is an ancillary project to the REGARDS study and is funded by the National Institute of Neurological Disorders and Stroke (NINDS).

Key Personnel:

David Roth, PhD Principal Investigator
Michelle Henry Research Specialist
Martinique Perkins Graduate Assistant

 

Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)

 

CREST is an NINDS-funded, investigator-initiated, prospective, randomized, multicenter clinical trial comparing the results of carotid endarterectomy (CEA) vs. carotid artery stenting (CAS) in both symptomatic and, more recently, asymptomatic participants. The primary endpoints are stroke, myocardial infarction, and death during a 30-day peri-procedural period and ipsilateral stroke thereafter. CREST has an anticipated enrollment of 2500 participants, approximately 1400 symptomatic and 1100 asymptomatic, making it the largest currently enrolling randomized trial comparing CAS and CEA in North America .

CREST also includes a lead-in phase for credentialing of interventionalists who have previously been trained and evaluated in CAS.

The first participant was enrolled in December 2000.

For more information, please visit the CREST web site: ( www.CRESTtrial.org )

Key Personnel at the Administrative Center (located at UMDNJ, Newark , New Jersey ) and Recruitment Center (located at Mayo Clinic, Jacksonville , Florida ) include:

Robert W. Hobson , II, MD Principal Investigator
Tom Brott , M.D. Co-Principal Investigator
Alice J. Sheffet , Ph.D Project Director
Jamie L. Roberts, BSH, CCRP Recruitment Coordinator

 

Key Personnel at the Statistical and Data Management Center (located at the School of Public Health , UAB)

 

Virginia J. Howard , MSPH Principal Investigator
Jenifer Voeks , PhD Co-investigator, Senior Epidemiologist
George Howard , DrPH Co-investigator, Senior Statistician
Jason Avery , MPH Project Manager
Robert Caldwell Assistant Data Manager
Martha Kellum , MS Statistician
Stephanie Martin, MS Statistician
Beth Baker , MS Statistician
Richard Mailhot , MS, MBA IT Manager
Raj Boddupalli Programmer
Sarat Ethakota Programmer

 

The REGARDS Study Aims

 

The overriding goal of the REGARDS study is to understand the underlying causes for the geographic and racial differences in stroke mortality. To meet this goal, the study will assess geographic and racial differences in stroke risk factors and observe geographic and racial differences in stroke incidence and case fatality. The study will focus on the identification of differences in the prevalence or severity of risk factors, and on differential susceptibility to risk factors, that may contribute to the geographic and racial differences in stroke mortality. Also, the effect of mobility on stroke risk (i.e., moving between regions with differential stroke mortality risk) will be assessed. Finally, the study will serve as a depository for genetic materials to assess the geographic and racial differences in genes for stroke or stroke risk factors.

Summary Study Design

REGARDS is a population-based longitudinal cohort study. A sample of 30,000 individuals over the age of 45 will be selected with equal representation of whites and African Americans, and men and women. Twenty percent (20%) of the sample will be selected from the “buckle” of the stroke belt, 30% from the stroke belt states (remainder of NC, SC, and GA, plus AL, MS, TN, AR, and LA), and the remaining 50% from the other 42 contiguous states.

Within each region, individuals will be recruited from defined lists of residents. Potential participants will be contacted by a combination of mail and telephone. Medical and family history will be obtained by telephone interview. An in-home physical examination will establish physical measures (blood pressure, height, weight, etc) and to obtain a sample of blood. Self-administered questionnaires will assess diet and other factors. Participants will be followed by telephone at six-month intervals for surveillance of potential stroke events. Hospital and medical records of potential events will be retrieved, and centrally reviewed to establish the presence, subtype, and severity of potential strok events. The participants will be provided the medical information regarding their major stroke risk factors, and will be provided a small cash reimbursement for their inconvenience.

Web Site: http://www.regardsstudy.org/

News: REGARDS offers answers that could help save lives

Staff:

 

Secondary Prevention of Small Subcortical Strokes (SPS3)

 

Main Goals

Secondary Prevention of Small Subcortical Strokes (SPS3)consists of two randomized, multicenter clinical trials that follow a 3 year NINDS-sponsored pilot study. It will enroll 2500 participants (20% of whom will be Hispanic Americans) with symptomatic, MRI-defined S3 without carotid stenosis or major cardiac sources of embolism at 35 clinical sites. Patients will be assigned, in a factorial design, to two interventions:

  1. Antiplatelet Intervention 325 mg/d vs. aspirin 325 mg/d plus clopidogrel 75mg/d.
  2. Blood Pressure Intervention: systolic blood pressure targets of 130 to 149 mmHg vs. <130 mmHg.

The antiplatelet comparison will be double-blinded, while the blood pressure intervention will be open-label with blinded assessment and verification of cognition and clinical events. Follow-up will be every three months for a mean of 3 years.
Main outcomes are:

  1. Recurrent stroke (ischemic and hemorrhagic)
  2. Cognitive decline
  3. Major vascular events

History

January 1991 - Consecutive case series of inpatients with acute stroke at two San Antonio hospitals revealed an increased frequency of lacunar strokes among Mexican-Americans, with ethnicity emerging as an independent predictor of lacunar stroke.

May 1998 - SPS3 pilot trial grant submitted to NIH-NINDS - new pilot clinical trials program

September 1999 -1st patient randomized into SPS3 pilot trial.

June 2002 - SPS3 grant application considered by NINDS Special Emphasis Panel. Priority score makes funding likely.

September 2002 - NINDS Council approves funding of SPS3.

February 2003 - Notice of Grant award received

April 2003 -1st patient randomized in San Antonio

May 2003 - 1st Investigator's Meeting held at La Cantera in San Antonio with 70 participants attending and 23 clinical sites represented

June 2003 -1st Clinical Site outside San Antonio (Boston) randomized the 1st patient

May 2004 - 2nd Investigator Meeting held in Santa Fe, New Mexico

 

Staff Members:

 

SPS3 Coordinating Center - University of Texas at San Antonio
Oscar Benavente, M.D. Principal Investigator
Robert Hart, M.D. Co-Principal Investigator
Carole White, Ph.D., R.N. SPS3 Study Coordinator
Ché Kelly SPS3 Administrator
Lesly Pearce Data Monitor

 

SPS3 Statistical Center - University of Alabama at Birmingham
Christopher Coffey, Ph.D Principal Investigator
Leslie McClure, Ph.D Lead Statistician
Mary Jo Sewell Program Coordinator II
Lisa Irby Program Coordinator II
Fekisha Vaughan Program Manager
Charles Allcorn Lead Programmer
Rajendra Majji Programmer

 

Data is entered at the clinical sites and transferred electronically to the Statistical Center on a real time basis by use of a secure web-based system. Each clinical site receives a CD-ROM with the complete SPS3 randomization/data entry system installation package and receives training on using the system. After the initial installation of the software, whenever a clinic starts up the SPS3 system, the system automatically communicates with the SPS3 server at the Statistical Center at UAB. Data is continuously transferred to the main SPS3 database and the local system is updated with the latest version of the program.