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Completed

NCT Number: NCT02346565

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

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?

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwick Park Hospital

Harrow, Middx, HA1 3UJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise ECG

Procedure

Stress Echocardiography

Procedure

Primary outcomes

  1. Comparison of Positive Predictive Value of each test for Coronary artery disease detection

    Time frame: 2 years

    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

  2. To compare the use of Downstream resource utilisation following allocated functional tests

    Time frame: 2 years

    Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2015
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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