NCT03565978

Cardiac Care Solution for Coronary Disease Follow up

Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD).

Detailed description

The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular (CVD) patients who were discharged from the hospital. The objectives include two parts: Objective 1: Assess the feasibilities of using the solution by means of questionnaire. Objective 2: Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease (CAD). Primary outcome: Compliance of coronary disease secondary prevention at 12 months. Secondary outcome: Compliance of coronary disease secondary prevention at 6 months. Self-management behavior evaluation at the 6 and 12 months. Medication compliance at 6 and 12 months assessed by self-reporting questionnaire. Control rates of risk factors at the 6 and 12 months (serum LDL-C, blood pressure, fasting serum glucose); quality of life at the 6 and 12 months (EQ-5D, Seattle angina questionnaire); MACE (Major Adverse Cardiac Event) within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for cardiac reason, unplanned coronary revascularization). The study will be a two arm, randomized control study. The intervention group will use an application installed on a Pad besides standard outpatient follow up, while the control group will receive standard outpatient follow up.

Conditions

• ST Segment Elevation Myocardial Infarction
• Non-ST Segment Elevation Myocardial Infarction
• Unstable Angina

Interventions

Type	Name	Description
DEVICE	BAMA solution	Use of BAMA cardiac post-discharge management solution for patients education and follow up management

Timeline

• Start date: 2016-04-08
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2018-06-21
• Last updated: 2020-03-05

Locations

1 site across 1 country: China