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

NCT06114615 | Recruiting DMC FDA Device

• 1 other identifier: 1972752
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

post-PCI; digital monitoring; cardiac rehabilitation

Outcome Measures

Primary Outcomes (6)

• blood pressure, systolic and diastolic

  1 month, 6 months

• readmission rate

  1 month, 6 months

• enrollment rate in cardiac rehabilitation

  1 month, 6 months

• rate of non-compliance to medications prescribed at discharge

  1 month, 6 months

• average ratings on the telehealth usability questionnaire

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

  six months

• patient rate of first follow up appointment

  1 month, 6 month

Secondary Outcomes (2)

• lipid profile

  one month, six months

• Major adverse cardiovascular events (MACE)

  one month, six months

Study Arms (2)

Discharged with LiveCare and Text Message Intervention

ACTIVE COMPARATOR

Patients receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.

Device: LiveCare; Behavioral: Text Messages

Discharged with Conventional Care

SHAM COMPARATOR

Patients do not receive blood pressure monitoring and text messages reminders for enrollment in cardiac rehab, follow up appointment, diet and exercise counseling.

Other: Conventional Care

Interventions

LiveCare DEVICE

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

Also known as: Blood Pressure and Weight Monitoring

Discharged with LiveCare and Text Message Intervention

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.

Discharged with LiveCare and Text Message Intervention

Conventional Care OTHER

No digital monitoring with LiveCare device and no text messages.

Discharged with Conventional Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center Division of Cardiovascular Medicine

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Surabhi Atreja, MD

CONTACT

(916) 734-2011; smatreja@ucdavis.edu

Lina Du, BS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)