NEtwork to Control ATherothrombosis (NEAT Registry)

Coronary Artery Disease Clinical Trial

— NEAT  

Official title:

Brazilian Registry of Atherothrombotic Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04677725
• Other study ID #: NEAT
• Status: Active, not recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Atherothrombosis
• Coronary Artery Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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