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NCT Number: NCT06114615

Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events

The study aims to support patients immediately after percutaneous coronary intervention (PCI) by implementing a telemonitoring program. Eligible patients have coronary heart disease and undergo PCI. The intervention group receives remote monitoring and text-based follow-up, with established health goals and education on using the telemonitoring application, along with necessary devices. The control group gets standard care. Outcomes measured include blood pressure, LDL levels, patient satisfaction, revascularization, and mortality. The study findings will enhance patient care after PCI and contribute evidence for widespread telemonitoring implementation in healthcare systems, aiding medical therapy and lifestyle modifications.

Recruiting

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Medical Center Division of Cardiovascular Medicine

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Surabhi Atreja, MD

CONTACT

[email protected]

916-734-6082

About this study

The study involves 200 participants divided into intervention and control groups, all diagnosed with coronary heart disease and treated with PCI. Upon discharge, the intervention group receives remote monitoring, text messages, and devices for self-management. Control group receives standard care. Recruitment is from cardiology and primary care clinics, with interpreters available. Study coordinator guides device setup during enrollment. Intervention group receives daily messages for a week, then weekly reminders and counseling. Messages are in English or Spanish as per preference. Patient data is collected, including demographics, medications, and outcomes such as blood pressure and readmission rates. Satisfaction is evaluated through surveys and interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.

Treatment and study plan

LiveCare

Device

Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.

Other names: Blood Pressure and Weight Monitoring

Text Messages

Behavioral

Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.

Conventional care

Other

No digital monitoring with LiveCare device and no text messages.

Primary outcomes

  1. blood pressure, systolic and diastolic

    Time frame: 1 month, 6 months

  2. readmission rate

    Time frame: 1 month, 6 months

  3. enrollment rate in cardiac rehabilitation

    Time frame: 1 month, 6 months

  4. rate of non-compliance to medications prescribed at discharge

    Time frame: 1 month, 6 months

  5. average ratings on the telehealth usability questionnaire

    Time frame: six months

    assess patient satisfaction with the teleheath program with 12 questions, each 1-7 points. Total of 84 points; higher score indicates greater satisfaction

  6. patient rate of first follow up appointment

    Time frame: 1 month, 6 month

Secondary outcomes

  1. lipid profile

    Time frame: one month, six months

  2. Major adverse cardiovascular events (MACE)

    Time frame: one month, six months

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Du, BS

CONTACT

Surabhi Atreja, MD

CONTACT

[email protected]

(916) 734-2011

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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