Early Cardiac Computed Tomography (CT) In Patients Admitted With Acute Chest Pain

NCT00767065 | Unknown

• 1 other identifier: CWRT/SP2008/1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Chest Pain

Outcome Measures

Primary Outcomes (1)

• Length of hospital admission

  At the end of initial hospital admission

Secondary Outcomes (4)

• NHS costs and cost-effectiveness over a one-year period

  One year

• Patient quality of life at 1, 6 and 12 months after admission

  1 year

• Patient anxiety about symptoms 1, 6 and 12 months after admission

  1 year

• The incidence of major adverse cardiovascular events (MACE) over a one year period.

  1 year

Study Arms (2)

Cardiac Computed Tomography (CCT)

ACTIVE COMPARATOR

Patients randomised to the CCT arm will undergo 128-channel cardiac computed tomography with delayed acquisition. CCT will be available Monday to Friday from 9am until 5pm. Patients will be entered into the study provided CCT can be undertaken within 24 hours of troponin result. Therefore, the only period during which a patient will be ineligible for inclusion will be between 5pm on a Friday and 9am the following Sunday. Studies will be reported at CWH by one of 2 experienced radiologists trained in CCT and results passed to the referring team on the same day.

Radiation: Cardiac Computed Tomography

Standard Care Arm

ACTIVE COMPARATOR

Patients randomised to the standard care arm will undergo further care as dictated by the responsible clinician. Except for CCT, all standard investigations will be available to the responsible clinician and may be used at their discretion. CCT does not form part of current in-patient management at our hospital.

Other: Standard care

Interventions

Cardiac Computed Tomography RADIATION

Patients randomised to the CCT arm will undergo 128-channel cardiac computed tomography with delayed acquisition. Patients will receive beta-blockade if necessary prior to the scan to achieve a heart rate of less than 70/min. An unenhanced scan will be performed in all patients to assess coronary artery calcium score. Patients will then undergo contrast enhanced CCT. After a bolus tracking acquisition, injection of 120mls iodinated contrast at 5ml/s will be followed by 40ml normal saline/contrast (in 50:50 proportion), also at 5ml/s. Imaging will be performed with a gated cardiac CT protocol. Where possible (stable rhythm and heart rate \<70bpm) a low dose technique will be utilised. When not possible a retrospective gating method will be employed. In the latter case the ECG will be used to assign the images to their respective phases of the cardiac cycle. 10 minutes after contrast injection, a second prospectively gated scan will be acquired to assess myocardial enhancement patterns.

Cardiac Computed Tomography (CCT)

Standard care OTHER

Further investigations as decided by the patient's clinical team, according to best normal practice. These may include some or all of: further blood tests, exercise stress testing and myocardial perfusion scintigraphy. These may be conducted either during the initial hospital admission, or subsequently as an outpatient.

Standard Care Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Simon Padley, MB BS BSc FRCP FRCR

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Padley, MB BS BSc FRCP FRCR

CONTACT

(0044) 020 8746 8000; s.padley@ic.ac.uk

Jim Stirrup, MB BS BSc MRCP

CONTACT

(0044) 020 7352 8121; j.stirrup@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: October 6, 2008

Record last verified: 2008-09

Locations

GB (1)