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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Co-designed cardiovascular brief intervention

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • NHS Lothian
    • Contact: Stacey Schulberg; Phone Number: 0131 242 6431; Email: stacey.schulberg@ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Patients assigned to usual clinical care
Experimental: Intervention; Patients will return to outpatients department to receive a cardiovascular brief intervention	Behavioral: Co-designed cardiovascular brief intervention; Patients will be randomised to a brief intervention where they will be informed of their high-sensitivity cardiac troponin value and cardiovascular risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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).	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac medication adherence	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.	90 days
Proportion of participants recruited from screening log	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.	90 days
The quantity of missing data at baseline and follow up	The proportion of missing data will be assessed from the case report forms.	90 days
The presence or increase of anxiety and/or depression	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.	90 days
Patient's acceptability and views of the cardiovascular brief intervention	will be explored through qualitative interviews with patients	120 days

Collaborators and Investigators

• Sponsor: University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cardiovascular Diseases
• Other Study ID Numbers: AC25029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No