Cardiovascular Primary Prevention Clinical Trial
— RISKOfficial title:
Cardiovascular Risk Stratification of Ambulatory Patients in Primary Prevention. RISK Study
| Verified date | July 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Argentina: Human Research Bioethics Committee |
| Study type | Observational [Patient Registry] |
This is an observational, cross-sectional, national multicenter study, trying to obtain
local data about the global cardiovascular risk profile of patients attending ambulatory
offices of general practitioners and cardiologists.
The aim of the study is to describe how physicians diagnose and stratify their patients in
cardiovascular primary prevention setting and to highlight if patients are stratify through
objective tools (risk scores and in this case, wich of them are used) or in subjective ways
(clinical evaluation).
| Status | Completed |
| Enrollment | 516 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients older than 18 years of age, who give their written consent to take part. - Patients without known vascular disease (primary prevention) under follow-up by the investigator, whose medical records have been initiated during the last 3 years. - Patients who have completed their baseline CV risk assessment Lipid lowering treatment naive patients at the time of the stratification. Exclusion Criteria: - Incomplete or missing medical record data. - Subjects with prior cardiovascular disease (peripheral vascular disease, coronary or cerebrovascular disease) symptomatic or asymptomatic. - Subjects with terminal status disease or short life expectancy. - Hypothyroidism without proper control. - Pregnancy. - Medical records compiled within a period longer than 3 years to the date of inclusion. |
Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Desciption of the assessment methods used to define the cardiovascular risk profile of patients attending outpatient medical consultation. | It will be evaluated the cardiovascular risk score for each patient. The proportion of use of each of the validated risk scores, as a tool of individual cardiovascular risk stratification and the proportion of use of a subjective assessment as tools of individual cardiovascular risk stratification used by general practitioners and cardiologists will be described. | Day 1 | No |
| Secondary | Comparison of the subjective individual risk assessment vs. the objective assessment obtained by the WHO risk score. | Comparison of the subjective individual risk assessment performed by the investigator for each patient at the moment of the risk stratification vs. the objective assessment obtained by the WHO risk score. | Day 1 | No |
| Secondary | Comparison of the objective individual risk assessment achieved by the use of any risk score chosen by the treating physician in his / her usual practice vs. the objective assessment obtained by WHO risk score. | Comparison of the objective individual risk assessment achieved by the use of any risk score chosen by the treating physician in his / her usual practice for each patient at the moment of the risk stratification vs. the objective assessment obtained by WHO risk score. | Day 1 | No |
| Secondary | Description of the treatment used, according to risk group and by the specialty of the treating physician. | Description of the pharmacological treatment implemented by the treating physician after risk stratification, according to cardiovascular risk group and by the specialty of the treating physician (cardiologists or GPs), such us Lipid Lowering drugs, antihypertensives, antiplatelet drugs, antidiabetic drugs. | Day 1 | No |
| Secondary | Description of the extent of use of other diagnostic methods to define the individual cardiovascular risk (imaging scans, biomarkers). | Description of use of other diagnostic methods to define the individual cardiovascular risk, such us PCR, Apo A / Apo B, Homocysteine, Neck Vessels Ecodoppler, Echocardiogram, Ca Score, PEG, Ecostress - Gamma camera, etc. | Day 1 | No |