Cardiovascular DiseasesACTION 2NCT06903442
Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department With Chest Pain: a Co-Production Approach. Phase 2.
A study testing Co-designed cardiovascular brief intervention in people with Cardiovascular Diseases, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. The investigators know this by taking a blood test (troponin) which looks at damage to the patient's heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Co-designed cardiovascular brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients who present to the Emergency Department with symptoms suggestive of acute coronary syndrome
- A maximum high-sensitivity cardiac troponin I between 5 ng/L and the sex-specific 99th centile.
- Resides in Scotland and has a CHI number
- Adults aged 18 and over
- No history of cardiovascular disease
- At least 1 modifiable cardiovascular risk factor: current smoker, hypertension (140/90 mmHg), hypercholesterolaemia (>6.0 mmol/L), overweight and obesity (BMI >25), hyperglycaemia or diabetes mellitus.
- Patients who are able to provide informed consent
Who cannot join
- Patients with a diagnosis of acute coronary syndrome during index presentation
- Patients who are not able to give informed consent
- Patients who do not speak English
- Patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention
- Patients with ongoing or planned cardiovascular investigations or interventions
- Patients with chronic kidney disease and a eGFR below 30 ml/min
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Lothian
Edinburgh
Stacey Schulberg, 0131 242 6431, stacey.schulberg@ed.ac.uk
About this study
Some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. The investigators know this by taking a blood test (troponin) which looks at damage to the patient's heart.
These patients are often sent home from hospital with no information about their risk of heart disease. A patient survey revealed that patients in the emergency department would like to receive more information about heart disease.
In this study the investigators will provide patients who are at increased risk of cardiovascular disease with their troponin value. The investigators will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. In a previous study the investigators carried out some interviews with patients to find out how their results should be delivered and what information should be included in a cardiovascular brief intervention. The investigators also asked them the best way to provide patients with this information. The aim of this part of the study it to determine if the new cardiovascular brief intervention helps patients understand their risk and if it results in them making changes to their health.
- Conditions
- Cardiovascular Diseases
- Being tested
- Co-designed cardiovascular brief intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-designed cardiovascular brief interventionBehavioural
Patients will be randomised to a brief intervention where they will be informed of their high-sensitivity cardiac troponin value and cardiovascular risk.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients assigned to usual clinical care |
| Intervention | Experimental | Patients will return to outpatients department to receive a cardiovascular brief intervention Receives: Behavioral: Co-designed cardiovascular brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Health
Cardiovascular health will be measured using a lifestyle questionnaire based on the American Heart Association's Life's Essential 8 measure of cardiovascular health (Lloyd-Jones, 2022). The components of Life's Essential 8 include (diet, physical activity, nicotine exposure, body mass index, sleep, blood pressure, blood glucose and blood cholesterol). Each component has a scoring metric of 0-100 (table 1) with a composite score of cardiovascular health being the average of all 8 components. A higher score represents better cardiovascular health.
Measured: 90 days
Secondary outcomes (3)
High sensitivity cardiac troponin concentrations
High-sensitivity cardiac troponin I will be assessed as an absolute value and change between baselines and 90 days for the secondary objective. Additional exploratory analyses will evaluate other high-sensitivity cardiac troponin assays and measures.
Measured: 90 days
Motivational readiness to make changes to improve their cardiovascular health
Patient's motivation will be assessed using a "readiness ruler" linear numeric scale (0-10)
Measured: 90 days
The difference in scores within each component of the Life's Essential 8 cardiovascular health score
Cardiovascular health will be measured using a lifestyle questionnaire based on the American Heart Association's Life's Essential 8 measure of cardiovascular health (Lloyd-Jones, 2022). The components of Life's Essential 8 include (diet, physical activity, nicotine exposure, body mass index, sleep, blood pressure, blood glucose and blood cholesterol).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start25 Aug 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903442
- Sponsor's protocol ID
- AC25029
- Acronym
- ACTION 2
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department With Chest Pain: a Co-Production Approach. Phase 2.
- ClinicalTrials.gov ID
- NCT06903442
- Acronym / sponsor ID
- ACTION 2 / AC25029
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 30 Mar 2025 (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.
Some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. The investigators know this by taking a blood test (troponin) which looks at damage to the patient's heart.
These patients are often sent home from hospital with no information about their risk of heart disease. A patient survey revealed that patients in the emergency department would like to receive more information about heart disease.
In this study the investigators will provide patients who are at increased risk of cardiovascular disease with their troponin value. The investigators will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. In a previous study the investigators carried out some interviews with patients to find out how their results should be delivered and what information should be included in a cardiovascular brief intervention. The investigators also asked them the best way to provide patients with this information. The aim of this part of the study it to determine if the new cardiovascular brief intervention helps patients understand their risk and if it results in them making changes to their health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients assigned to usual clinical care |
| Intervention | Experimental | Behavioral: Co-designed cardiovascular brief interventionPatients will return to outpatients department to receive a cardiovascular brief intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who present to the Emergency Department with symptoms suggestive of acute coronary syndrome
- A maximum high-sensitivity cardiac troponin I between 5 ng/L and the sex-specific 99th centile.
- Resides in Scotland and has a CHI number
- Adults aged 18 and over
- No history of cardiovascular disease
Key exclusion criteria (6 listed)
- Patients with a diagnosis of acute coronary syndrome during index presentation
- Patients who are not able to give informed consent
- Patients who do not speak English
- Patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention
- Patients with ongoing or planned cardiovascular investigations or interventions
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 |
|---|---|---|
| Co-designed cardiovascular brief interventionPatients will be randomised to a brief intervention where they will be informed of their high-sensitivity cardiac troponin value and cardiovascular risk. | Behavioural | Intervention |
Primary outcome
Cardiovascular Health
Time frame: 90 days
Cardiovascular health will be measured using a lifestyle questionnaire based on the American Heart Association's Life's Essential 8 measure of cardiovascular health (Lloyd-Jones, 2022). The components of Life's Essential 8 include (diet, physical activity, nicotine exposure, body mass index, sleep, blood pressure, blood glucose and blood cholesterol). Each component has a scoring metric of 0-100 (table 1) with a composite score of cardiovascular health being the average of all 8 components. A higher score represents better cardiovascular health.
3 secondary outcomes
High sensitivity cardiac troponin concentrations
Time frame: 90 days
Motivational readiness to make changes to improve their cardiovascular health
Time frame: 90 days
The difference in scores within each component of the Life's Essential 8 cardiovascular health score
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-designed cardiovascular brief intervention in people with Cardiovascular Diseases, run by University of Edinburgh at 1 site in United Kingdom.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Health (time frame: 90 days). 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 Jun 2026.