Stress Echocardiography Versus Exercise ECG (ExECG) in Women With Chest Pain

London North West Healthcare NHS Trust

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Stress Echocardiography; Procedure: Exercise ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT02346565

RD14/86

Details and patient eligibility

About

The overall question the investigators would like to help answer is whether SE with or without MCE data can be widely used as a first line investigation in women with no previous history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In order to answer this question the investigators will look at the following:

i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of CAD?

ii) What is the additive value of myocardial perfusion data to wall motion data for predicting significant CAD on angiography and future cardiac events in women?

iii) What is the additive value of Carotid ultrasonography in a large population of women referred for stress testing?

Full description

The investigators plan to perform a prospective study on all women seen in our RACPC with no previous history of CAD and intermediate pre-test probability of CAD as determined by National Institute for Health and Care Excellence (NICE) guidelines, who require a functional test as part of their assessment. All patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study.

Patients who can perform greater than 5 metabolic equivalents (METS) on the Duke Activity Status Index (DASI) questionaire will be randomised between undergoing an Exercise ECG (Ex-ECG) or Exercise Stress Echo (ESE). The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents. Patients who do not meet this criteria, will undergo a pharmacological stress echocardiogram using Dobutamine (DSE), including Myocardial Contrast Echocardiography (MCE). Investigations will continue to be performed as per standard clinical departmental protocols as described below. In addition, all patients will undergo carotid ultrasonography. The techniques used are described for completeness as they are all well-established in clinical practice.

Enrollment: 416 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30 years and above
• No previous history of Coronary Artery Disease
• Chest pain of presumed cardiac origin, which has occurred in the last month prior to the clinic appointment.

Exclusion criteria

• Electrocardiogram diagnostic of cardiac ischaemia and/or infarction (ST-segment deviations>0.5mm, or T-wave inversion).
• Previous history of Coronary Artery Disease
• Chest pain in the last 24 hours
• Inability to provide informed consent
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

Exercise ECG

Other group

Description:

Patients will undergo an exercise test using the standard Bruce protocol. Standard end points of exercise testing will include: fatigue, severe ischaemia (severe chest pain, \>2mm ST depression on ECG), hypertension (systolic BP\>220mmHg), hypotension, pre-syncope or arrhythmia.

Treatment:

Procedure: Exercise ECG

Stress Echocardiography

Other group

Description:

A two-dimensional echocardiogram will be performed in the lateral decubitus position. Digitized images of the left ventricle (LV) will be obtained in the parasternal long-axis, short-axis, and apical four-, two-, and three-chamber views. In the case of exercise stress echo, images will be acquired at rest and immediately (within 90 seconds) after peak exercise. In the case of dobutamine stress echo, images will be acquired at rest, at the end of stage one of dobutamine administration (10mcg/Kg/min) and at peak stress.

Treatment:

Procedure: Stress Echocardiography