Coronary Artery DiseaseRisk-CADNCT04966117
Risk-guided Disease Management in Coronary Artery Disease
A study testing Risk-Guided DMP in people with Coronary Artery Disease and Chronic Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Coronary Artery Disease, Chronic Disease, Nurse's Role
- What is being tested?
- Risk-Guided DMP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jul 2021to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Hospitalised with a primary diagnosis of heart failure; OR
- eGFR <30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
Show all 10Show fewer
- Valve disease only; OR
- Requiring palliative care; OR
- Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
- Participating in another study with a potential but unknown effect on outcome.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
About this study
Official title: A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
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.
Read the detailed description
The Investigators aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided DMP, to reduce readmissions following CAD, thereby enhancing recovery and survivorship.
The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize reduced hospital readmissions or death for high-risk patients randomized to Risk-Guided DMP compared to usual care.
Methods
This proposed study is an effectiveness and feasibility trial of a risk guided DMP to reduce hospital readmissions in CAD patients. The Investigators seek to do this by adopting innovative approaches to:
- a community-based secondary prevention DMP, ii) supported by a novel m-Health app (SmartCR developed by CardiHab) to address components of a Cardiac Rehabilitation (CR) program, and iii) selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) criteria.
Patients aged 30-74 years who have been hospitalised with CAD will be recruited. Electronic medical records from Western Health (Sunshine or Footscray hospital) will be routinely screened (twice per week) to invite patients to participate. Heartwest cardiologists will also identify patients from their surgical lists.
Baseline measures will include clinical features (including severity and number of affected vessels) and biochemistry (troponin, B-type natriuretic protein, renal function) from medical records; patient self-reported socio-demographic features, cognitive function using the Montreal Cognitive Assessment as an important predictor of readmission, mental health via the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) questionnaire and quality of life using the Assessment of Quality of Life (AQoL-8D) questionnaire. Exercise capacity will be quantified by peak oxygen uptake (VO2 peak) and cardiac function will be assessed via two-dimensional echocardiography.
Risk evaluation will be performed by PEGASUS-TIMI 54 criteria for selection of high risk patients [score ≥5] who have an increased risk of a secondary event.
- Conditions
- Coronary Artery Disease, Chronic Disease, Nurse's Role
- Being tested
- Risk-Guided DMP, Usual Care
- Keywords
- Cardiac rehabilitation, Disease Management Program, Secondary Prevention, Rehospitalization, mHealth
- Medical subject headings
- Coronary Artery Disease, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Guided DMPBehavioural
Patients will be assigned a cardiac nurse to help manage their heart condition who will:
- develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors.
- provide health coaching at pre-specified times over 12 months via telehealth (phone or video call) to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
- facilitate cardiac rehabilitation via a smart phone or tablet app (called SmartCR). This app monitors health and physical activity, has prompted tasks to do and delivers education via video, audio and written articles. The information from this app can be used by the cardiac nurse during telehealth follow-up.
- invite participation to a supervised 6-week group exercise program which will require using our on-site gym.
Usual CareBehavioural
Usual care patients will receive standard cardiology care as scheduled that includes adherence to guideline-based care (medications and physical activity), education (self-care), a treatment plan to manage co-morbidities, early post-discharge follow-up/support and routine preventative care.
| Study group | Role | What they receive |
|---|---|---|
| Risk-Guided DMP | Experimental | The intervention is a 12 month disease management program after hospital discharge for coronary artery disease that is overseen by a cardiac nurse. Receives: Behavioral: Risk-Guided DMP |
| Usual Care | Active comparator | Usual care patients will receive standard cardiology care. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization or death
Unplanned all-cause hospital readmission or death
Measured: 90 days post discharge
Secondary outcomes (5)
Hospitalization or death
Short term unplanned all-cause hospital readmission or death
Measured: 30 days post discharge
Provider adherence to best practice guidelines
Increased prescription of lipid-lowering, anti-hypertensive (e.g. beta-blocker) and antiplatelet agents
Measured: 12 months post discharge
Risk factor control - lipids
Change in LDL-cholesterol (mmol/L)
Measured: 12 months post discharge
Risk factor control - blood pressure
Change in systolic and diastolic blood pressure (mmHg)
Measured: 12 months post discharge
Health well-being
Change in quality of life (via AQoL-8D total scores and 8 dimension scores)
Measured: 12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start17 Jul 2021
- Primary completion10 Oct 2024
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, open, parallel-group randomized controlled trial of a disease management program (intervention group) to reduce hospital readmissions or death compared to usual care (control group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heartwest, University of Melbourne, Queen's University, Belfast, Western Health
- Responsible party
- Sponsor
- Investigators
- Melinda J Carrington, PhD, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966117
- Sponsor's protocol ID
- 266/21
- Acronym
- Risk-CAD
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data to be shared will be all of the individual participant data collected during the trial, after de-identification and underlying published results only. The data will be available to only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator. The data will be available for any approved purpose.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
- ClinicalTrials.gov ID
- NCT04966117
- Acronym / sponsor ID
- Risk-CAD / 266/21
- Conditions
- Coronary Artery Disease, Chronic Disease, Nurse's Role
- Keywords
- Cardiac rehabilitation, Disease Management Program, Secondary Prevention, Rehospitalization, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Collaborators
- Heartwest, University of Melbourne, Queen's University, Belfast, Western Health
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Investigators aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided DMP, to reduce readmissions following CAD, thereby enhancing recovery and survivorship.
The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize reduced hospital readmissions or death for high-risk patients randomized to Risk-Guided DMP compared to usual care.
Methods
This proposed study is an effectiveness and feasibility trial of a risk guided DMP to reduce hospital readmissions in CAD patients. The Investigators seek to do this by adopting innovative approaches to:
- a community-based secondary prevention DMP, ii) supported by a novel m-Health app (SmartCR developed by CardiHab) to address components of a Cardiac Rehabilitation (CR) program, and iii) selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) criteria.
Patients aged 30-74 years who have been hospitalised with CAD will be recruited. Electronic medical records from Western Health (Sunshine or Footscray hospital) will be routinely screened (twice per week) to invite patients to participate. Heartwest cardiologists will also identify patients from their surgical lists.
Baseline measures will include clinical features (including severity and number of affected vessels) and biochemistry (troponin, B-type natriuretic protein, renal function) from medical records; patient self-reported socio-demographic features, cognitive function using the Montreal Cognitive Assessment as an important predictor of readmission, mental health via the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder (GAD-7) questionnaire and quality of life using the Assessment of Quality of Life (AQoL-8D) questionnaire. Exercise capacity will be quantified by peak oxygen uptake (VO2 peak) and cardiac function will be assessed via two-dimensional echocardiography.
Risk evaluation will be performed by PEGASUS-TIMI 54 criteria for selection of high risk patients [score ≥5] who have an increased risk of a secondary event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, open, parallel-group randomized controlled trial of a disease management program (intervention group) to reduce hospital readmissions or death compared to usual care (control group)
| Arm | Type | Receives |
|---|---|---|
| Risk-Guided DMP | Experimental | Behavioral: Risk-Guided DMPThe intervention is a 12 month disease management program after hospital discharge for coronary artery disease that is overseen by a cardiac nurse. |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care patients will receive standard cardiology care. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
- Hospitalised with a primary diagnosis of heart failure; OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Guided DMPPatients will be assigned a cardiac nurse to help manage their heart condition who will: 1. develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors. 2. provide health coaching at pre-specified times over 12 months via telehealth (phone or video call) to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes. 3. facilitate cardiac rehabilitation via a smart phone or tablet app (called SmartCR). This app monitors health and physical activity, has prompted tasks to do and delivers education via video, audio and written articles. The information from this app can be used by the cardiac nurse during telehealth follow-up. 4. invite participation to a supervised 6-week group exercise program which will require using our on-site gym. | Behavioural | Risk-Guided DMP |
| Usual CareUsual care patients will receive standard cardiology care as scheduled that includes adherence to guideline-based care (medications and physical activity), education (self-care), a treatment plan to manage co-morbidities, early post-discharge follow-up/support and routine preventative care. | Behavioural | Usual Care |
Primary outcome
Hospitalization or death
Time frame: 90 days post discharge
Unplanned all-cause hospital readmission or death
5 secondary outcomes
Hospitalization or death
Time frame: 30 days post discharge
Provider adherence to best practice guidelines
Time frame: 12 months post discharge
Risk factor control - lipids
Time frame: 12 months post discharge
Risk factor control - blood pressure
Time frame: 12 months post discharge
Health well-being
Time frame: 12 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. The data to be shared will be all of the individual participant data collected during the trial, after de-identification and underlying published results only. The data will be available to only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Principal Investigator. The data will be available for any approved purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda J Carrington, PhD principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Guided DMP in people with Coronary Artery Disease and Chronic Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization or death (time frame: 90 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.