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

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06903442
• Lead Sponsor: University of Edinburgh

Brief 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. We know this by taking a blood test (troponin) which looks at damage to their 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 we will provide patients who are at increased risk of cardiovascular disease with their troponin value. We will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. In a previous study we carried out some interviews with patients to find out how we should deliver their results and what information they would like to receive in a cardiovascular brief intervention. We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04-30
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• i) Patients who present to the Emergency Department with symptoms suggestive of acute coronary syndrome ii) A maximum high-sensitivity cardiac troponin I between 5 ng/L and the sex-specific 99th centile.

iii) Resides in Scotland and has a CHI number iv) Adults aged 18 and over v) No history of cardiovascular disease vi) 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.

vii) Patients who are able to provide informed consent

Exclusion Criteria

• i) Patients with a diagnosis of acute coronary syndrome during index presentation ii) Patients who are not able to give informed consent iii) Patients who do not speak English iv) Patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention v) Patients with ongoing or planned cardiovascular investigations or interventions vi) Patients with chronic kidney disease and a eGFR below 30 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiovascular Health	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.

Secondary Outcome Measures

Name	Time	Method
The difference in scores within each component of the Life's Essential 8 cardiovascular health score	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).
High sensitivity cardiac troponin concentrations	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.
Motivational readiness to make changes to improve their cardiovascular health	90 days	Patient's motivation will be assessed using a "readiness ruler" linear numeric scale (0-10)