NEtwork to Control ATherothrombosis (NEAT Registry)

Sponsor
Hospital do Coracao (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04677725
Collaborator
Bayer (Industry)
2,000
1
30
66.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Brazilian Registry of Atherothrombotic Disease
    Actual Study Start Date :
    Sep 30, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients receiving evidence based therapies to reduce cardiovascular risk [Baseline]

      DOMAIN 1: Appropriate use of antithrombotic therapy

    2. Percentage of patients receiving evidence based therapies to reduce cardiovascular risk [Baseline]

      DOMAIN 2: Cholesterol control

    3. Percentage of patients receiving evidence based therapies to reduce cardiovascular risk [Baseline]

      DOMAIN 3: Blood pressure control

    4. Percentage of patients receiving evidence based therapies to reduce cardiovascular risk [Baseline]

      DOMAIN 4: Glycemic control / diabetes treatment

    5. Percentage of patients receiving evidence based therapies to reduce cardiovascular risk [Baseline]

      DOMAIN 5: Weight control

    6. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Do Coração São Paulo SP Brazil 05410001

    Sponsors and Collaborators

    • Hospital do Coracao
    • Bayer

    Investigators

    • Principal Investigator: Pedro de Barros e Silva, MD, MHS, PhD, Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital do Coracao
    ClinicalTrials.gov Identifier:
    NCT04677725
    Other Study ID Numbers:
    • NEAT
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022