NCT04677725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

December 8, 2020

Last Update Submit

November 2, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk

    6 and 12 months

  • Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia)

    baseline, 06 and 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary and peripheral arterial disease in an outpatient setting

You may qualify if:

  • Patients ≥45 years followed in ambulatory setting with ≥1 of the following 3 criteria:
  • 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
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Do Coração

São Paulo, São Paulo, 05410001, Brazil

Location

Related Publications (1)

  • de Barros E Silva PGM, do Nascimento CT, Pedrosa RP, Nakazone MA, do Nascimento MU, de Araujo Melo L, Junior OLS, Zimmermann SL, de Melo RMV, Bergo RR, Precoma DB, Tramujas L, Lima EG, Dantas JMM, do Amaral Baruzzi AC, Flumignan RLG, de Oliveira Paiva MSM, Gowdak LHW, de Carvalho PN, de Figueiredo Neto JA, Silvestre OM, Fioranelli A, Vieira RD', Horak ACP, Miyada DHK, Kojima FCS, de Oliveira JS, de Oliveira Silva L, Pavanello R, Ramacciotti E, Lopes RD; NEAT Investigators. Primary results of the brazilian registry of atherothrombotic disease (NEAT). Sci Rep. 2024 Feb 20;14(1):4222. doi: 10.1038/s41598-024-54516-9.

MeSH Terms

Conditions

Coronary Artery DiseasePeripheral Arterial DiseaseThrombosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAtherosclerosisPeripheral Vascular DiseasesEmbolism and Thrombosis

Study Officials

  • Pedro de Barros e Silva, MD, MHS, PhD

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 21, 2020

Study Start

September 30, 2020

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations