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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise ECG
Stress Echocardiography
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwick Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Exercise ECG

Stress Echocardiography

Arm 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.

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.

Outcomes

Primary Outcome Measures

Comparison of Positive Predictive Value of each test for Coronary artery disease detection
To compare positive predictive value of each test for the detection of obstructive CAD defined as ≥ 70% luminal diameter narrowing in one or more epicardial coronary arteries or their major branches during invasive coronary arteriography
To compare the use of Downstream resource utilisation following allocated functional tests
Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2015
Last Updated
October 17, 2022
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02346565
Brief Title
Stress Echocardiography Versus Exercise ECG (ExECG) in Women With Chest Pain
Official Title
The Role of Contemporary Stress Echocardiography Techniques in the Initial Assessment of Women With No Previous History of Coronary Artery Disease (CAD) Who Present With Chest Pain of Recent Onset. Stress Echocardiography vs Exercise ECG as First Line Investigation in This Population. Potential for Higher Diagnostic Accuracy Cost Saving.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise ECG
Arm Type
Other
Arm 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.
Arm Title
Stress Echocardiography
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Exercise ECG
Intervention Type
Procedure
Intervention Name(s)
Stress Echocardiography
Primary Outcome Measure Information:
Title
Comparison of Positive Predictive Value of each test for Coronary artery disease detection
Description
To compare positive predictive value of each test for the detection of obstructive CAD defined as ≥ 70% luminal diameter narrowing in one or more epicardial coronary arteries or their major branches during invasive coronary arteriography
Time Frame
2 years
Title
To compare the use of Downstream resource utilisation following allocated functional tests
Description
Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
Middx
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

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

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