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Recruiting 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.

No phase Interventional Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Co-designed cardiovascular brief intervention.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cardiovascular Health [Time frame: 90 days]
Secondary outcome measures (3)
  • High sensitivity cardiac troponin concentrations [Time frame: 90 days]
  • Motivational readiness to make changes to improve their cardiovascular health [Time frame: 90 days]
  • The difference in scores within each component of the Life's Essential 8 cardiovascular health score [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United Kingdom · 1 center
  • NHS Lothian — Edinburgh

Identifiers

NCT: NCT06903442 · AC25029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗