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Non-Disabling Cerebral Infarction: The VISP Collection

Sponsor
National Institute for Neurological Disorders and Stroke, NIH

The Vitamin Intervention for Stroke Prevention (VISP) Clinical Trial Collection is a valuable and finite set of DNA samples for investigating cerebrovascular disease.

This special collection of the NINDS Human Genetics Resource Center DNA and Cell Line Repository contains more than 2,000 DNA samples from individuals with non-disabling cerebral infarction. A rich clinical dataset is associated with each sample, including multiple questionnaires and longitudinal data. VISP samples have been arrayed as a series of plates. Because there is only DNA, and cell lines are not available, all requests for samples will be reviewed by NINDS staff and adjudicated based on NINDS programmatic relevance.

The VISP study is a double-masked, randomized, multi-center clinical trial based out of Wake Forest University School of Medicine, and headed by Dr. James Toole. The investigators hypothesized that reducing homocysteine levels with high-dose multivitamin therapy would decrease the risk of recurrent cerebral infarction or coronary heart disease in patients with a history of non-disabling cerebral infarction. This was investigated by, in addition to best medical and surgical management, a clinical trial comparing outcomes following high-dose folic acid, vitamin B6, and vitamin B12 supplements to outcomes following lower doses of these vitamins. Patients enrolled were at least 35 years old with a non-disabling ischemic stroke within 120 days, and screening plasma H(e) > the 25th percentile of benchmark population data. While the study outcome was negative, these well-characterized adult subjects with known ischemic stroke have been provided as a genetic and phenotypic resource to the scientific community.

The VISP Collection DNA samples were generated by Molecular Staging Incorporated (which has since been purchased by Qiagen) using whole-genome-amplification, and thus represent a finite resource. Each DNA sample and associated clinical data is from a patient with non-disabling cerebral infarction. The samples have been verified by Coriell for gender and concentration only, and are arrayed on 96-well plates for high-throughput analyses. All samples are from affected subjects, and are separated onto plates by race. Gender distribution on each plate is representative of gender distribution in the VISP Collection.

VISP Clinical Data

Clincal data, including longitudinal data, for VISP subjects was collected on 11 separate forms and questionnaires. The NINDS Repository and Wake Forest University School of Medicine have made all of these data available. Click on the links below to view the data dictionaries for each questionnaire or form.

Brief Description 

Each of these 19 panels contain 5 micrograms of whole-genome-amplified DNA per well from 94 individuals with non-disabling cerebral infarction. Each sample has been normalized to 150 ng/ul. Two wells remain empty on each 96-well plate for orientation and for placement of laboratory controls. Control panels are also available, as well as additional cerebrovascular disease samples.

Data collected on the subjects corresponding to these samples consist of the VISP Clinical Data, including 11 medical forms and questionnaires, as well as longitudinal data. These data are available as an excel file. Inclusion/Exclusion criteria for the VISP study are documented.

All samples and data were collected with informed consent under local IRB-approved protocols. These samples are generously shared by Dr. James Toole.

Please cite the plate number and the NINDS Repository in any publications, and share those references with the NINDS Repository  (ninds@coriell.org). Portions or all of this statement may be used in publications relevant to this panel.

Publication Describing the VISP Study

James F. Toole, MD; M. René Malinow, MD; Lloyd E. Chambless, PhD; J. David Spence, MD, FRCPC, FAHA; L. Creed Pettigrew, MD, MPH; Virginia J. Howard, MSPH; Elizabeth G. Sides, MEd; Chin-Hua Wang, PhD; Meir Stampfer, MD, DrPH. Lowering homocysteine in patients with ischemic stroke to prevent recurrent stroke, myocardial infarction, and death: the Vitamin Intervention for Stroke Prevention (VISP) randomized controlled trial. JAMA. 2004 Feb 4;291:565-75. PMID: 14762035

J. David Spence, MD, FRCPC, FAHA; Virginia J. Howard, MSPH; Lloyd E. Chambless, PhD; M. René Malinow, MD; L. Creed Pettigrew, MD, MPH; Meir Stampfer, MD, DrPH; James F. Toole, MD. Vitamin Intervention for Stroke Prevention (VISP) Trial: Rationale and Design. Neuroepidemiology, 2001;20:16-25. PMID: 11174041

J. David Spence, MD, FRCPC, FAHA; Heejung Bang, PhD; Lloyd E. Chambless, PhD Meir J. Stampfer, MD, DrPH. Vitamin Intervention for Stroke Prevention Trial: An Efficacy Analysis. Stroke 2005;36:2404. PMID: 16239629

VISP Non-Disabling Cerebral Infarction Panels