Coronary Artery DiseaseNEATNCT04677725
NEtwork to Control ATherothrombosis (NEAT Registry)
An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Peripheral Arterial Disease, Atherothrombosis
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Sep 2020to Apr 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary and peripheral arterial disease in an outpatient setting
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
DOMAIN 1: Appropriate use of antithrombotic therapy
Measured: Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
DOMAIN 2: Cholesterol control
Measured: Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
DOMAIN 3: Blood pressure control
Measured: Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
DOMAIN 4: Glycemic control / diabetes treatment
Measured: Baseline
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
DOMAIN 5: Weight control
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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
Measured: baseline, 06 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start30 Sep 2020
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Pedro de Barros e Silva, MD, MHS, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677725
- Sponsor's protocol ID
- NEAT
- Acronym
- NEAT
- Status last verified
- Nov 2022
- First submitted
- 8 Dec 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38378735
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Registry of Atherothrombotic Disease
- ClinicalTrials.gov ID
- NCT04677725
- Acronym / sponsor ID
- NEAT / NEAT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary and peripheral arterial disease in an outpatient setting
Key inclusion criteria (11 listed)
- Documented coronary disease (≥1 criteria must apply):
- Documented symptomatic Peripheral Arterial Disease (≥1 criteria must apply):
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: Baseline
DOMAIN 1: Appropriate use of antithrombotic therapy
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: Baseline
DOMAIN 2: Cholesterol control
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: Baseline
DOMAIN 3: Blood pressure control
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: Baseline
DOMAIN 4: Glycemic control / diabetes treatment
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: Baseline
DOMAIN 5: Weight control
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
Time frame: 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.
2 secondary outcomes
Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk
Time frame: 6 and 12 months
Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia)
Time frame: baseline, 06 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 38378735de 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.
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro de Barros e Silva, MD, MHS, PhD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.