Clinical trial NCT04677725: NEtwork to Control ATherothrombosis (NEAT Registry)
Official title: Brazilian Registry of Atherothrombotic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Peripheral Arterial Disease
Atherothrombosis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2020-12-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary and peripheral arterial disease in an outpatient setting

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
measure: Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
timeFrame: Baseline
Secondary outcomes:
measure: Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk
timeFrame: 6 and 12 months
measure: Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia)
timeFrame: baseline, 06 and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Do Coração
state: SP
Study officials:
affiliation: Faculty
name: Pedro de Barros e Silva, MD, MHS, PhD
role: PRINCIPAL_INVESTIGATOR
References: