Coronary Artery Disease Clinical Trial
— NEATOfficial title:
Brazilian Registry of Atherothrombotic Disease
Verified date | November 2022 |
Source | Hospital do Coracao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting.
Status | Active, not recruiting |
Enrollment | 2000 |
Est. completion date | April 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients =45 years followed in ambulatory setting with =1 of the following 3 criteria: 1. Documented coronary disease (=1 criteria must apply): - Stable angina - History of Unstable Angina - History of coronary angioplasty/stenting - History of coronary artery bypass graft - Myocardial infarction within the last 20 years 2. Documented symptomatic Peripheral Arterial Disease (=1 criteria must apply): - Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or - Previous limb or foot amputation for arterial vascular disease, or - History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio < 0.90, or 2) Significant peripheral artery stenosis (=50%) documented by angiography, or by duplex ultrasound. Exclusion Criteria: - Patients from institutions that don't provide the Institutional Authorization Term, - Incapacity of follow-up in one year according to investigator judgment (severe neuropsychiatric condition, life expectancy < 12 months) |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Do Coração | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital do Coracao | Bayer |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 1: Appropriate use of antithrombotic therapy | Baseline | |
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 2: Cholesterol control | Baseline | |
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 3: Blood pressure control | Baseline | |
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 4: Glycemic control / diabetes treatment | Baseline | |
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 5: Weight control | Baseline | |
Primary | Percentage of patients receiving evidence based therapies to reduce cardiovascular risk | DOMAIN 6: Non-pharmacological intervention: In this domain, there are 2 items to be evaluated: 1) No smoking; 2) Physical exercise = 150 minutes per week. | Baseline | |
Secondary | Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk | Patient should receive all of the following to consider complete evidence based therapy: Appropriate use of antithrombotic therapy; Cholesterol control; Blood pressure control; Glycemic control / diabetes treatment; Weight control; Non-pharmacological intervention | 6 and 12 months | |
Secondary | Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia) | blood pressure, cholesterol and glycemia levels at baseline, 06 and 12 months | baseline, 06 and 12 months |
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