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NCT Number: NCT06903442

Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department With Chest Pain: a Co-Production Approach. Phase 2.

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Co-designed cardiovascular brief intervention

Behavioral

Patients will be randomised to a brief intervention where they will be informed of their high-sensitivity cardiac troponin value and cardiovascular risk.

Primary outcomes

  1. 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.

Secondary outcomes

  1. High sensitivity cardiac troponin concentrations

    Time frame: 90 days

    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.

  2. Motivational readiness to make changes to improve their cardiovascular health

    Time frame: 90 days

    Patient's motivation will be assessed using a "readiness ruler" linear numeric scale (0-10)

  3. The difference in scores within each component of the Life's Essential 8 cardiovascular health score

    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).

Other outcomes

  1. Cardiac medication adherence

    Time frame: 90 days

    Medication use and adherence will be assessed using the Medication Adherence Reporting Scale (MARS-5) (Horne 1999). The participants will rate 5 different adherence behaviours on a five-point scale. The scores are combined to provide a total score, with the higher scores indicating a higher level of reported adherence to medication.

  2. Proportion of participants recruited from screening log

    Time frame: 90 days

    Recruitment rates and patients lost to follow up will be assessed from the trial consort diagram which will detail the participants' pathway though the study.

  3. The quantity of missing data at baseline and follow up

    Time frame: 90 days

    The proportion of missing data will be assessed from the case report forms.

  4. The presence or increase of anxiety and/or depression

    Time frame: 90 days

    Anxiety and depression will be assessed using the Hospital and Anxiety Depression Scale (HADS) (Zigmond and Snaith 1983). The HADS consists of 14 questions which can be scored from 0 to 3. Anxiety and depression are scored separately with a maximum score of 21 for each category.

  5. Patient's acceptability and views of the cardiovascular brief intervention

    Time frame: 120 days

    will be explored through qualitative interviews with patients

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Acronym: ACTION 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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