Acute Coronary SyndromeNCT04995900
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
A study testing Community education in people with Acute Coronary Syndrome and Myocardial Infarction, Acute, run by Monash University at 1 site in Australia.
Trial summary
The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response. The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Acute
- What is being tested?
- Community education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,240 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2022to 31 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Adult residents of the eight local government areas -
Exclusion Criteria: Adults not residing in the eight local government areas.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response.
The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. The clusters are eight local government areas (LGAs) in Victoria, Australia. The main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six LGAs throughout the study period with an ED diagnoses of acute coronary syndrome.
Read the detailed description
Primary objectives:
To determine if targeted heart health education will:
- Increase ambulance use in ACS patients (main primary outcome);
- Decrease patient and prehospital delay times in ACS patients;
- Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
- Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.
Secondary objectives
- To determine if targeted heart health education:
- Reduces the incidence of out-of-hospital cardiac arrest;
- Improves survival in OHCA patients;
- Improves survival in ACS patients;
- Improves survival and ACS patients;
- Increases presentations to ED for ACS and unspecified chest pain; and
- Increases the rates of calls to ambulance for chest pain and non-chest pain.
- Increases the rate of Heart Health Checks.
Intervention: To meet the objectives of the study, we will employ HM coordinators for each of the eight high-risk LGAs to organise and deliver our HM education program using HM materials and Partner resources.
Design: The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.
Over the 16-month study period, the eight LGAs will move into the intervention phase at two month intervals. As four LGAs are in close proximity, these LGAs will switch from control to intervention periods at the same time to avoid possible contamination.
- Being tested
- Community education
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community educationOther
Also called Local campaign
Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention period with active Heart Matters education delivered Receives: Other: Community education |
| Control | No intervention | Control period with no Heart Matters education delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulance use for ACS
The proportion of ACS patients that present to ED by ambulance.
Measured: 16 months
Secondary outcomes (21)
Median ACS patient delay time
The median ACS patients delay time (time from symptom onset to decision to seek medical attention).
Measured: 16 months
ACS patient delay time <60 minutes
The proportion of ACS patients with patient delay times <60 minutes
Measured: 16 months
Median ACS patient prehospital delay time
The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
Measured: 16 months
ACS patients prehospital delay times <120 minutes
The proportion of ACS patients with prehospital delay times <120 minutes
Measured: 16 months
Awareness of own risk of heart attack
The proportion of adult members of the community who are aware of their own risk of heart attack.
Measured: 0-2 months and 6-8 months
Awareness of heart attack as a leading cause of death
The proportion of adult members of the community who identify heart disease a leading cause of death
Measured: 0-2 months and 6-8 months
Awareness of heart attack risk factors
The proportion of adult members of the community who identify cardiovascular risk factors
Measured: 0-2 months and 6-8 months
Number of correctly named heart attack risk factors
The number of correctly named cardiovascular risk factors by adult members of the community
Measured: 0-2 months and 6-8 months
Awareness of heart attack signs and symptoms
The proportion of adult members of the community aware of heart attack symptoms
Measured: 0-2 months and 6-8 months
Number of correctly named heart attack signs and symptoms
The number of correctly named ACS symptoms by adult members of the community
Measured: 0-2 months and 6-8 months
Confidence in knowing how to act
The proportion adult members of the community who are confident about what they would do if experiencing a heart attack
Measured: 0-2 months and 6-8 months
Ambulance use in scenarios
The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.
Measured: 0-2 months and 6-8 months
Rates of Heart Health Checks
Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
Measured: 16 months
Rates of ACS ED presentations
The rates of ED presentations that are ACS
Measured: 16 months
Rates of unspecified chest pain ED presentations
Rates of ED presentations that are unspecified chest pain
Measured: 16 months
ACS ED presentations via GPs
Proportion of ACS ED presentations via General Practitioners
Measured: 16 months
Rates of ACS survival
The proportion of ACS patients surviving to hospital discharge
Measured: 16 months
Incidence of OHCA
incidence of out-of-hospital cardiac arrest
Measured: 16 months
Rates of OHCA
Rates out-of-hospital cardiac arrest survival
Measured: 16 months
Calls to ambulance for chest pain
Proportion of chest pain (event type 10) calls to ambulance
Measured: 16 months
Calls to ambulance for non- chest pain
Proportion of non-chest pain emergency calls to ambulance
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Crossover
- Model description
- The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation, Australia, Department of Health, Victorian Government, Ambulance Victoria
- Responsible party
- Principal investigator, Janet, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995900
- Sponsor's protocol ID
- 291276657
- Other IDs
- 1180282
- Status last verified
- Jun 2023
- First submitted
- 30 Jul 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to data is restricted and is not available for sharing at the individual patient level.
Publications
Bray JE, Nehme Z, Finn JC, Kasza J, Woods J, Clark RA, Stub D, Cadilhac DA, Kim J, Smith BJ, Cartledge S, Beauchamp A, Bowden R, Dodge N, Flemming-Judge E, Chow C, Cox N, van Gaal W, Nadurata V, Cameron P; Heart Matters Investigators. Heart Attack Education and EMS Response in High-Risk, Low EMS Usage Areas: A Stepped-Wedge Cluster-Randomized Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268823. doi: 10.1001/jamanetworkopen.2026.8823.
PubMed 42043820Bray JE, Nehme Z, Finn JC, Kasza J, Clark RA, Stub D, Cadilhac DA, Buttery AK, Woods J, Kim J, Smith BJ, Smith K, Cartledge S, Beauchamp A, Dodge N, Walker T, Flemming-Judge E, Chow C, Stewart M, Cox N, van Gaal W, Nadurata V, Cameron P. A protocol for the Heart Matters stepped wedge cluster randomised trial: The effectiveness of heart attack education in regions at highest-risk. Resusc Plus. 2023 Jul 25;15:100431. doi: 10.1016/j.resplu.2023.100431. eCollection 2023 Sep.
PubMed 37555197
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT04995900
- Acronym / sponsor ID
- 291276657
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,240 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Heart Foundation, Australia, Department of Health, Victorian Government, Ambulance Victoria
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 Aug 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.
The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response.
The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. The clusters are eight local government areas (LGAs) in Victoria, Australia. The main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six LGAs throughout the study period with an ED diagnoses of acute coronary syndrome.
Detailed description
Primary objectives:
To determine if targeted heart health education will:
- Increase ambulance use in ACS patients (main primary outcome);
- Decrease patient and prehospital delay times in ACS patients;
- Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
- Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.
Secondary objectives
- To determine if targeted heart health education:
- Reduces the incidence of out-of-hospital cardiac arrest;
- Improves survival in OHCA patients;
- Improves survival in ACS patients;
- Improves survival and ACS patients;
- Increases presentations to ED for ACS and unspecified chest pain; and
- Increases the rates of calls to ambulance for chest pain and non-chest pain.
- Increases the rate of Heart Health Checks.
Intervention: To meet the objectives of the study, we will employ HM coordinators for each of the eight high-risk LGAs to organise and deliver our HM education program using HM materials and Partner resources.
Design: The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.
Over the 16-month study period, the eight LGAs will move into the intervention phase at two month intervals. As four LGAs are in close proximity, these LGAs will switch from control to intervention periods at the same time to avoid possible contamination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Community educationIntervention period with active Heart Matters education delivered |
| Control | No intervention | –Control period with no Heart Matters education delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Community educationAlso: Local campaignHeart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources. | Other | Intervention |
Primary outcome
Ambulance use for ACS
Time frame: 16 months
The proportion of ACS patients that present to ED by ambulance.
21 secondary outcomes
Median ACS patient delay time
Time frame: 16 months
ACS patient delay time <60 minutes
Time frame: 16 months
Median ACS patient prehospital delay time
Time frame: 16 months
ACS patients prehospital delay times <120 minutes
Time frame: 16 months
Awareness of own risk of heart attack
Time frame: 0-2 months and 6-8 months
Awareness of heart attack as a leading cause of death
Time frame: 0-2 months and 6-8 months
Awareness of heart attack risk factors
Time frame: 0-2 months and 6-8 months
Number of correctly named heart attack risk factors
Time frame: 0-2 months and 6-8 months
Awareness of heart attack signs and symptoms
Time frame: 0-2 months and 6-8 months
Number of correctly named heart attack signs and symptoms
Time frame: 0-2 months and 6-8 months
Confidence in knowing how to act
Time frame: 0-2 months and 6-8 months
Ambulance use in scenarios
Time frame: 0-2 months and 6-8 months
Rates of Heart Health Checks
Time frame: 16 months
Rates of ACS ED presentations
Time frame: 16 months
Rates of unspecified chest pain ED presentations
Time frame: 16 months
ACS ED presentations via GPs
Time frame: 16 months
Rates of ACS survival
Time frame: 16 months
Incidence of OHCA
Time frame: 16 months
Rates of OHCA
Time frame: 16 months
Calls to ambulance for chest pain
Time frame: 16 months
Calls to ambulance for non- chest pain
Time frame: 16 months
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 15 Jun 2023.
- Derived from this study: PubMed 42043820Bray JE, Nehme Z, Finn JC, Kasza J, Woods J, Clark RA, Stub D, Cadilhac DA, Kim J, Smith BJ, Cartledge S, Beauchamp A, Bowden R, Dodge N, Flemming-Judge E, Chow C, Cox N, van Gaal W, Nadurata V, Cameron P; Heart Matters Investigators. Heart Attack Education and EMS Response in High-Risk, Low EMS Usage Areas: A Stepped-Wedge Cluster-Randomized Trial. JAMA Netw Open. 2026 Apr 1;9(4):e268823. doi: 10.1001/jamanetworkopen.2026.8823.
- Derived from this study: PubMed 37555197Bray JE, Nehme Z, Finn JC, Kasza J, Clark RA, Stub D, Cadilhac DA, Buttery AK, Woods J, Kim J, Smith BJ, Smith K, Cartledge S, Beauchamp A, Dodge N, Walker T, Flemming-Judge E, Chow C, Stewart M, Cox N, van Gaal W, Nadurata V, Cameron P. A protocol for the Heart Matters stepped wedge cluster randomised trial: The effectiveness of heart attack education in regions at highest-risk. Resusc Plus. 2023 Jul 25;15:100431. doi: 10.1016/j.resplu.2023.100431. eCollection 2023 Sep.
- Individual participant dataSharing planned: No. Access to data is restricted and is not available for sharing at the individual patient level.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community education in people with Acute Coronary Syndrome and Myocardial Infarction, Acute, run by Monash University 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?
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 15 Jun 2023. 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?
Ambulance use for ACS (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995900, which also lists 2 linked publications.
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 15 Jun 2023.