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

Primary Purpose

Acute Chest Pain

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiac Computed Tomography
Standard care
Sponsored by
Chelsea and Westminster NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Chest Pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chelsea and Westminster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cardiac Computed Tomography (CCT)

Standard Care Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of hospital admission

Secondary Outcome Measures

NHS costs and cost-effectiveness over a one-year period
Patient quality of life at 1, 6 and 12 months after admission
Patient anxiety about symptoms 1, 6 and 12 months after admission
The incidence of major adverse cardiovascular events (MACE) over a one year period.

Full Information

First Posted
October 3, 2008
Last Updated
October 3, 2008
Sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00767065
Brief Title
Early Cardiac Computed Tomography (CT) In Patients Admitted With Acute Chest Pain
Acronym
EXACCT
Official Title
The Role of Early X-Ray Cardiac Computed Tomography in Patients Admitted With Acute Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, British Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Chest Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cardiac Computed Tomography (CCT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Cardiac Computed Tomography
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital admission
Time Frame
At the end of initial hospital admission
Secondary Outcome Measure Information:
Title
NHS costs and cost-effectiveness over a one-year period
Time Frame
One year
Title
Patient quality of life at 1, 6 and 12 months after admission
Time Frame
1 year
Title
Patient anxiety about symptoms 1, 6 and 12 months after admission
Time Frame
1 year
Title
The incidence of major adverse cardiovascular events (MACE) over a one year period.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Padley, MB BS BSc FRCP FRCR
Phone
(0044) 020 8746 8000
Email
s.padley@ic.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Stirrup, MB BS BSc MRCP
Phone
(0044) 020 7352 8121
Email
j.stirrup@rbht.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Padley, MB BS BSc FRCP FRCR
Organizational Affiliation
Chelsea and Westminster NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

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

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