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

NCT06903442 | Recruiting

• 1 other identifier: AC25029
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• High sensitivity cardiac troponin concentrations

  90 days

• Motivational readiness to make changes to improve their cardiovascular health

  90 days

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

  90 days

Other Outcomes (5)

• Cardiac medication adherence

  90 days

• Proportion of participants recruited from screening log

  90 days

• The quantity of missing data at baseline and follow up

  90 days

Study Arms (2)

Standard care

NO INTERVENTION

Patients assigned to usual clinical care

Intervention

EXPERIMENTAL

Patients will return to outpatients department to receive a cardiovascular brief intervention

Behavioral: Co-designed cardiovascular brief intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: August 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

GB (1)