Risk Factor, Cardiovascular Clinical Trial
Official title:
Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Their Current Status of Risk Factors Control
This study will delineate the risk profile of patients with isolated cerebral or coronary ischemia and those with combined disease. The study will also evaluate current management status of those patients and any unmet needs.This aim is proposed to be achieved by studying 3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to be 1000 patients.
Background: most of available data are designed to show risk profile of either coronary or
cerebral ischemia, few data compared both risk profiles or tried to outline risk factors for
combined ischemia.
The aim is to compare risk profile of isolated coronary, cerebral ischemia or combined
disease to find out specific profile for each territory affection. Current management of
risk factors will be documented to find out any unmet needs specially for sicker patients
with combined ischemia.
Material and methods: 3 groups of patients representing coronary, cerebral and combined
ischemia.will be studied.
Documentation of coronary ischemia will be either by history of coronary care unit
admission, ECG documenting an infarction or ischemia, other noninvasive testing, previous
coronary intervention or coronary artery bypass grafting. Documentation of cerebral ischemia
will be by history, examination for a neurological deficit or any imaging modality
documenting cerebral ischemia (brain CT, MRI or duplex whether for extra or intracranial
vessels).
Risk factor analysis will be for the known risk factors like, age, sex, family history,
smoking, recurrent events (like more than one coronary event), sedentary life, waist/hip
ratio, BMI, diabetes(history, duration, current medication and current control status,
HbA1c), hypertension (history, duration, current drug treatment and current control status).
hypercholesterolemia (history, duration, drug treatment and control with current evaluation
of LDL, HDL, TG, ApoB/ApoA), hs-CRP, presence of AF( drug treatment).
Full patient data will be obtained in a Case Report Form (CRF) based format. CRF format will
be designed by the steering committee. Investigators at clinics or centers who agree to
share, will be committed to fulfill this CRF and send electronic form to central workstation
for database saving.
Filling the CRF will be based on a single interview between the investigator and the
patient, and any missing data or investigation that mandates another interview will be
allowed to complete the CRF within a period of 30 days.
Center or investigator agreement will be signed first to be involved in the study and to
receive the CRF.
All patients will sign a written consent to share in the study.
Data analysis will be presented as mean or numbers (%). The significance of relation between
qualitative variables will be analysed by chi-square test or Fisher's exact test as
indicated. The distribution of means among groups will be analysed by student t testor ANOVA
as appropriate.
Correlation between quantitative variables will be studied by correlation coefficient.
Independent predictors of primary outcomes will be analysed by logistic regression analysis
and cox regression analysis as indicated.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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