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A multicenter, randomized controlled clinical trial on the impact of HeartMed PCI digital out of hospital management on the clinical prognosis of patients with coronary heart disease and hyperlipidemia undergoing PCI surgery

A multicenter, randomized controlled clinical trial on the impact of HeartMed PCI digital out of hospital management on the clinical prognosis of patients with coronary heart disease and hyperlipidemia undergoing PCI surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094863
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Digital follow-up group:Digital Clinical Management System

Sponsors

Tangdu Hospital, Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old=6.2mmol/L, or TG>=2.3mmol/L, or HDL-C<=1.0mmol/L); 4. Patient is willing to follow the study protocol and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of moderate to severe valve disease; 2. Patients receiving intra aortic balloon counterpulsation and tracheal intubation; 3. History of dilated cardiomyopathy, perinatal cardiomyopathy, chemotherapy induced cardiomyopathy, hereditary hypertrophic cardiomyopathy, invasive cardiomyopathy, and viral myocarditis; 4. Patients with malignant tumors or those with an expected lifespan of less than 1 year; 5. Serious liver dysfunction (ALT or AST exceeding 3 times the upper limit of the normal range, or total bilirubin>1.5mg/dl) and renal dysfunction (eGFR<30ml/min/1.73m^2) caused by non cardiac reasons; 6. Pregnant women or patients with pregnancy plans within one year; 7. History of drug or alcohol abuse within the past 12 months; 8. Patients with mental illness or unable to cooperate in completing the study; 9. Individuals with disabilities in using smartphones; 10. Participate in other clinical studies within one month prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Device-oriented composite endpoints;

Secondary

MeasureTime frame
All-Cause Mortality;Indicators (blood pressure, heart rate, LDL) attainment rate;Readmission rate for cardiovascular disease;In stent restenosis and in stent thrombosis;MACE event;

Countries

China

Contacts

Public ContactLi Yan

Tangdu Hospital, Fourth Military Medical University

profleeyan@163.com+86 138 9289 0227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026