Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:36 AM
Study NCT ID:
NCT07332494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Remote Management for Care and Continuous Optimization Versus Usual Care in Patients With Coronary Heart Disease (DigiCare-CHD)
Sponsor:
Beijing Anzhen Hospital
Organization:
Study Overview
Official Title:
Digital Remote Management for Care and Continuous Optimization Versus Usual Care in Patients With Coronary Heart Disease (DigiCare-CHD)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigiCare-CHD
Brief Summary:
The DigiCare-CHD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated the efficacy of a smartphone-based digital remote management platform compared to usual care in achieving dual goal attainment of blood pressure and LDL-cholesterol levels in patients with coronary heart disease following percutaneous coronary intervention.
Detailed Description:
"Coronary heart disease (CHD) remains a leading cause of global mortality. While percutaneous coronary intervention (PCI) significantly improves acute survival, patients continue to face substantial residual cardiovascular risk driven by the progression of systemic atherosclerosis. Rigorous management of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) is imperative for secondary prevention. However, achieving simultaneous targets (BP \< 130/80 mmHg and LDL-C \< 1.4 mmol/L) in real-world practice is challenging due to clinical inertia and suboptimal patient adherence. Traditional outpatient follow-up is often fragmented and reactive, failing to provide the continuous monitoring required for optimal risk factor control.
The DigiCare-CHD trial serves as a prospective, multicenter, open-label randomized controlled trial designed to enroll 792 patients who have successfully undergone PCI for acute or chronic coronary syndromes. Participants will be randomized 1:1 to either the Digital Remote Management group or the Usual Care group, with a follow-up period of 12 months.
Patients in the intervention arm will utilize a digital remote management platform. This system integrates home monitoring to track BP, lipid profiles, and physical activity. Key features include AI-driven alerts for abnormal values, automated decision support for medication titration (verified by physicians), and targeted health education. The primary endpoint is the rate of dual goal attainment for BP and LDL-C at 12 months. DigiCare-CHD aims to establish a proactive, closed-loop management strategy to effectively reduce residual cardiovascular risk and improve long-term prognosis in the post-PCI population."
The DigiCare-CHD trial serves as a prospective, multicenter, open-label randomized controlled trial designed to enroll 792 patients who have successfully undergone PCI for acute or chronic coronary syndromes. Participants will be randomized 1:1 to either the Digital Remote Management group or the Usual Care group, with a follow-up period of 12 months.
Patients in the intervention arm will utilize a digital remote management platform. This system integrates home monitoring to track BP, lipid profiles, and physical activity. Key features include AI-driven alerts for abnormal values, automated decision support for medication titration (verified by physicians), and targeted health education. The primary endpoint is the rate of dual goal attainment for BP and LDL-C at 12 months. DigiCare-CHD aims to establish a proactive, closed-loop management strategy to effectively reduce residual cardiovascular risk and improve long-term prognosis in the post-PCI population."
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: