Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular Health
timeFrame: 90 days
Secondary outcomes:
measure: High sensitivity cardiac troponin concentrations
timeFrame: 90 days
measure: Motivational readiness to make changes to improve their cardiovascular health
timeFrame: 90 days
measure: The difference in scores within each component of the Life's Essential 8 cardiovascular health score
timeFrame: 90 days
Other outcomes:
measure: Cardiac medication adherence
timeFrame: 90 days
measure: Proportion of participants recruited from screening log
timeFrame: 90 days
measure: The quantity of missing data at baseline and follow up
timeFrame: 90 days
measure: The presence or increase of anxiety and/or depression
timeFrame: 90 days
measure: Patient's acceptability and views of the cardiovascular brief intervention
timeFrame: 120 days
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