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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04677725
Other study ID # NEAT
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 30, 2020
Est. completion date April 2023

Study information

Verified date November 2022
Source Hospital do Coracao
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting.


Description:

National multicenter registry in Brazil with initial plan of 25 sites from the 5 Brazilian regions. It will be coordinated by HCOR Research Institute which will perform regulatory, data and site management beyond academic leadership.NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting with 12 months of follow-up with collection of data at baseline, 6 months and 12 months.


Recruitment information / eligibility

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)

Study Design


Locations

Country Name City State
Brazil Hospital Do Coração São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
Hospital do Coracao Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

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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