NEtwork to Control ATherothrombosis (NEAT Registry) (NEAT)

Brazilian Registry of Atherothrombotic Disease

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Atherothrombosis

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05410001
      • Hospital do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary and peripheral arterial disease in an outpatient setting

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	DOMAIN 1: Appropriate use of antithrombotic therapy	Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	DOMAIN 2: Cholesterol control	Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	DOMAIN 3: Blood pressure control	Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	DOMAIN 4: Glycemic control / diabetes treatment	Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk	DOMAIN 5: Weight control	Baseline
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Bayer
• Investigators: Principal Investigator: Pedro de Barros e Silva, MD, MHS, PhD, Faculty

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: NEAT (NEAT002)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No