Clinical trial NCT00767065: Early Cardiac Computed Tomography (CT) In Patients Admitted With Acute Chest Pain
Official title: The Role of Early X-Ray Cardiac Computed Tomography in Patients Admitted With Acute Chest Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Chest Pain
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: British Heart Foundation
First posted: 2008-10-06
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomised trial comparing early Cardiac Computed Tomography (CCT) to current standard practice for diagnosis of acute chest pain in patients at low to intermediate risk of having coronary artery disease (CAD), in a UK setting. We hypothesise that early CCT can reduce length of admission, reduce NHS costs and improve quality of life whilst being at least as safe as standard practice.

Detailed description: Coronary Artery Disease (CAD) kills more people in the UK than any other condition, and causes symptoms of angina (chest pain) in many more. Acute chest pain accounts for approximately 600,000 NHS admissions per annum, but this includes many other types of chest pain not due to heart problems. Examination, blood tests and an electrocardiogram (ECG) are used to try and decide the cause of chest pain.

Many patients have a low risk of CAD and can be discharged without further investigation. Others are at high risk of CAD and must have further tests such as invasive coronary angiography. Unfortunately in many patients the initial tests are equivocal and they are felt to have an intermediate probability of CAD. Investigation of symptoms in this group may take place in the in-patient setting, warranting a hospital stay of several days, or alternatively some investigations may be performed as an out-patient with subsequent time spent on waiting lists. This results in extensive use of NHS resources and anxiety for the patients whilst awaiting diagnosis, often needlessly as approximately half of patients admitted with acute chest pain are eventually discharged without a cardiac cause found.

The new technique of cardiac computed tomography (CCT) offers rapid non-invasive diagnosis of CAD. If disease is detected further investigations can be planned; when excluded, patients may be safely discharged. Detection of clinically insignificant disease will initiate primary preventative strategies but excludes CAD as the cause of acute symptoms. We will randomise 250 patients presenting to Chelsea and Westminster Hospital with acute chest pain who have intermediate likelihood of CAD to early CCT or current standard practice. We hypothesise that, when compared to standard practice, early CCT will reduce admission length, reduce NHS and other costs and improve quality of life without an increase in adverse events.

Eligibility criteria: Inclusion Criteria:

1. Admission with suspected cardiac chest pain
2. \>40 years of age
3. EITHER Low likelihood of CAD according to DFC and troponin\>0.03 but \<3 OR Intermediate likelihood of CAD according to DFC
4. Written informed consent

Exclusion Criteria:

1. ECG consistent with acute myocardial infarction (ST elevation, new left bundle branch block)
2. Ongoing chest pain with dynamic ECG changes
3. Haemodynamic or respiratory instability
4. Serum troponin ≥3
5. Previous percutaneous coronary intervention or coronary artery bypass grafting
6. Admission to hospital between 5pm Friday and 9am Sunday
7. Contraindication to negative chronotropic agents
8. Maximum heart rate \>70bpm (including after pharmacologic treatment)
9. Renal dysfunction (Creat\>150 micromol/l)
10. Pregnancy or childbearing potential
11. Allergy or previous intolerance of iodinated contrast

Primary outcomes:
measure: Length of hospital admission
timeFrame: At the end of initial hospital admission
Secondary outcomes:
measure: NHS costs and cost-effectiveness over a one-year period
timeFrame: One year
measure: Patient quality of life at 1, 6 and 12 months after admission
timeFrame: 1 year
measure: Patient anxiety about symptoms 1, 6 and 12 months after admission
timeFrame: 1 year
measure: The incidence of major adverse cardiovascular events (MACE) over a one year period.
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Simon Padley, MB BS BSc FRCP FRCR
role: PRINCIPAL_INVESTIGATOR
References: