NEtwork to Control ATherothrombosis (NEAT Registry)

Active, not recruiting

• Conditions: Atherothrombosis; Coronary Artery Disease; Peripheral Arterial Disease

• Registration Number: NCT04677725
• Lead Sponsor: Hospital do Coracao

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-03
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk	6 and 12 months	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
Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia)	baseline, 06 and 12 months	blood pressure, cholesterol and glycemia levels at baseline, 06 and 12 months

Trial Locations

Locations (1)

Hospital Do Coração; 🇧🇷 São Paulo, SP, Brazil