Request for Funding

Mentor: Dion Graybeal, M.D.
Department: Neurology
Room number: CS5.616
Mail Code: 8897
Phone number: 8-3748
E-mail: dion.graybeal@utsouthwestern.edu
Project title: Clinical trials in patients with strokes

Human subjects IRB approved project number (where applicable):
SWISS: IRB#0600-275 / PRoFESS: IRB#012004-005 / SPS3: IRB#1102-620

Animal subjects IRB approved project number (where applicable): N/A

Project Type: Patient Based Research

Brief Description of Project:
SWISS-Siblings With Ischemic Stroke Study: This NIH study seeks a one-time blood draw from a proband (patient) and a sibling (pedigree) who have both had ischemic strokes. The NIH is researching a genetic link between siblings with strokes. Blood draws are done by the sponsor.
Students will help with identifying potential patients and giving them information on the study. All stoke admissions would be screened.

PRoFESS-Prevention Regimen For Effectively avoiding Second Strokes: Boehringer Ingelheim Pharmaceutical sponsors this study, which investigates the use of Aspirin, Clopidogrel, Aggrenox, and Micardis in various regimens to prevent second strokes. Students will be trained in phlebotomy and will be doing blood draws for follow-up patients in this study. They will also be trained in giving ECGs and blood pressure monitoring. After training for the NIHSS (stroke scale evaluation), they will be administering the NIHSS to patients in the study. Other evaluations for completion of the case report forms for each patient may be performed by the students.

SPS3-Secondary Prevention of Small Subcortical Strokes: This NIH study compares treatment of strokes with Aspirin plus Clopidogrel or Placebo. A second arm of the study is randomizing a patient to 2 blood pressure targets (between 130-149 or below 130). Students will assist in taking blood pressures, administering various stroke scales (after training), doing ECGs, and entering data into the computer for the sponsor.

Other Clinical Trials:
1. The students will attend the Patient Care Planning meeting each morning to discuss the stroke patients and determine which patients may qualify for clinical trial studies (all stroke studies will be included in this screening). They will report findings to various study coordinators.
2. Screening logs for each study will be filled out daily after the Patient Care Planning meeting.
3. Students will familiarize themselves with all stroke study protocols to help in recruitment and for overall administration of the Stroke Clinical Trial Program.
4. Students will work with Dr. Graybeal, Dr. Unwin, Dr. Johnson and with the study coordinator, J. Gregory Wright.

Previous Research Activities or Publications with Medical Students:

Dr. Hal Unwin and Dr. Mark Johnson have mentored summer medical student research fellowships since 1998.

In a recent study, Comparison of BNP and TEE in Patients with Recent Ischemic Stroke or TIA (BNP)" (IRB# 0702-390), students helped for two summers to recruit patients and compile data from consented patients. Students assisted in closing the study and compiling statistical data. They also designed a summary poster. Students working on this project were: Katrina Emmett, Craig Migden, Ari Magill, and Chris Pierotti.

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