An interventional study of Co-designed cardiovascular brief intervention in Cardiovascular Diseases, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 118 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients assigned to usual clinical care
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.
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.
Time frame: 90 days
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.
Time frame: 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)
Time frame: 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).
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days
Patient's acceptability and views of the cardiovascular brief intervention
will be explored through qualitative interviews with patients
Time frame: 120 days
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
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University of Edinburgh