跳至主要内容
临床试验/NCT06903442
NCT06903442招募中不适用

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

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
118
试验地点
1
主要终点
Cardiovascular Health

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Standard care

No Intervention

Patients assigned to usual clinical care

Intervention

Experimental

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

干预措施: Co-designed cardiovascular brief intervention (Behavioral)

结局指标

主要结局

Cardiovascular Health

时间窗: 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. A higher score represents better cardiovascular health.

Cardiovascular Health

时间窗: 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. A higher score represents better cardiovascular health.

次要结局

  • The difference in scores within each component of the Life's Essential 8 cardiovascular health score(90 days)
  • High sensitivity cardiac troponin concentrations(90 days)
  • Motivational readiness to make changes to improve their cardiovascular health(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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