NCT04966117Completed
Risk-guided Disease Management in Coronary Artery Disease
A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
Coronary artery disease (CAD) is the number one killer of Australians with a high risk for a recurrent event(s) and hospital readmission. Many of these readmissions can be prevented with better management to control the problem of CAD. A disease management program, led by nurses who interact with other health professionals/providers, can help with education and counselling, taking medications correctly and making healthy lifestyle changes for higher risk patients. Newer models of disease management programs make use of mobile devices (such as an "app") and telehealth (by phone or video call) to monitor and manage health which could facilitate CAD management. Therefore, the aim of this study is to test this type of disease management program (DMP) compared to standard care for reducing hospital readmissions or death in people with CAD who are at high risk of being readmitted. The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize that high-risk patients randomized to Risk-Guided CAD will have reduced hospital readmissions or death compared with those randomized to usual care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 29 Jun 2021
- Start date
- 17 Jul 2021
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- Baker Heart and Diabetes Institute
- Diseases
- Coronary artery disease
- NCT number
- NCT04966117
What you commit to
- Study type: Interventional
- Participants enrolled: 101
- From 17 Jul 2021 to the primary completion date, 10 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
Other illness
- Hospitalised with a primary diagnosis of heart failure; OR
- Valve disease only; OR
Lab values
- eGFR \<30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
Other
- Inability to provide written informed consent; OR
- Non-English speaking; OR
- Inability to attend clinic visits; OR
- Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR
- Requiring palliative care; OR
- Participating in another study with a potential but unknown effect on outcome.
Who the study is looking for
- Aged between 30 to 74 years; AND
- Hospitalised with CAD or other eligible cardiac procedure or condition including acute myocardial infarction (STEMI or NSTEMI), unstable angina, coronary artery bypass grafting or percutaneous coronary intervention; AND
- Defined as higher risk (score \>= 5) by PEGASUS-TIMI 54 criteria; AND
- Eligible for Medicare.
Age in the registry: 30 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baker Heart and Diabetes Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.