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

NCT ID: NCT02346565

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-09-30

Brief Summary

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?

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Exercise ECG

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.

Group Type: OTHER

Exercise ECG

Intervention Type: PROCEDURE

Stress Echocardiography

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.

Group Type: OTHER

Stress Echocardiography

Intervention Type: PROCEDURE

Interventions

Exercise ECG

Intervention Type: PROCEDURE

Stress Echocardiography

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London North West Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwick Park Hospital

Harrow, Middx, United Kingdom

Countries

United Kingdom

Other Identifiers

RD14/86

Identifier Type: -

Identifier Source: org_study_id