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Digital program aims to slash heart disease risk by lowering cholesterol

NCT ID NCT05622929

Disease control Sponsor: Hospital Israelita Albert Einstein Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a digital quality improvement program to help doctors better manage LDL (bad) cholesterol in patients with heart disease. Over 1,400 adults with established cardiovascular disease participated. The program used smartphone tools to improve treatment and follow guidelines, aiming to reduce the risk of future heart problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,465 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patient Eligibility Criteria: Inclusion Criteria: * Capable of using a smartphone with iOS or Android System AND * Established ASCVD, including: 1. Coronary Artery Disease (CAD): * Prior myocardial infarction * Prior coronary revascularization - percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) * Angiographic or computerized tomography (CT)-imaging evidence of coronary atherosclerosis (≥ 50% stenosis in at least one major epicardial coronary artery) 2. Stroke: • Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus) 3. Peripheral Artery Disease (PAD): * Prior documentation of a resting ankle-brachial index ≤ 0.9 * History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery * Prior non-traumatic amputation of a lower extremity due to peripheral artery disease * History of prior percutaneous or surgical carotid artery revascularization * Carotid Stenosis \> 50% on prior angiography or ultrasound AND * Provision of informed consent Exclusion Criteria: * Patients with a recent cardiovascular event, less than 3 months prior to study inclusion * Patients with LDL-C ≤ 50 mg/dL * Current participation in other clinical trials involving lipid lowering treatments * Patients that do not consent to trial participation Cluster Eligibility Criteria: Inclusion Criteria: * Outpatient Clinics from public or private hospitals OR, Private Practices, which assist patients with previous ASCVD on secondary prevention that provide a unit/institution authorization form for participation in the trial AND * Minimum monthly volume of 20 ASCVD patients Exclusion Criteria: * Clusters that do not provide the unit/institution authorization form.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease cardiovascular disorder Dyslipidemias hyperlipidemia inherited lipid metabolism disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Cardiovascular diseases Dyslipidemias

Contacts and locations

Locations

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe, Brazil

  • Centro de Pesquisas Clínicas Dr Marco Mota

    Maceió, Brazil

  • Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas

    Fortaleza, Brazil

  • Clínica Silvestre Santé

    Rio Branco, Brazil

  • Hospital Carlos Fernando Malzoni

    Matão, São Paulo, Brazil

  • Hospital Evangélico de Vila Velha

    Vila Velha, Brazil

  • Hospital Municipal de Aparecida de Goiânia

    Goiânia, Brazil

  • Hospital Regional Hans Dieter Schmidt

    Joinville, Santa Catarina, Brazil

  • Hospital Regional Presidente Prudente

    Presidente Prudente, Brazil

  • Hospital Ruy Azeredo

    Goiânia, Brazil

  • Hospital Santa Lúcia

    Poços de Caldas, Minas Gerais, Brazil

  • Hospital São Paulo (UNIFESP)

    São Paulo, Brazil

  • Hospital São Paulo Universidade Federal de São Paulo

    São Paulo, Brazil

  • Hospital Universitário João de Barros Barreto

    Belém, Brazil

  • Hospital Universitário São Francisco de Assis

    Bragança Paulista, São Paulo, Brazil

  • Hospital da Bahia

    Salvador, Estado de Bahia, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Brazil

  • Hospital e Maternidade Angelina Caron

    Campina Grande do Sul, Paraná, Brazil

  • Instituto Atena de Pesquisa Clínica

    Natal, Brazil

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Brazil

  • Instituto de Cardiologia Dante Pazzanese

    São Paulo, Brazil

  • Instituto de Cardiologia de Santa Catarina

    São José, Brazil

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo, Brazil

  • Irmandade da Santa Casa de Misericórdia de Marilia

    Marília, São Paulo, Brazil

  • Santa Casa de Curitiba

    Curitiba, Brazil

  • Santa Casa de Porto Alegre

    Porto Alegre, Brazil

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu

    Botucatu, Brazil

  • Unidade Hospital Municipal Antônio Giglio

    Osasco, Brazil

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