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Rapid Assessment of Potential Ischaemic Heart Disease With CTCA (RAPID-CTCA)

This study is currently recruiting participants.
Verified September 2017 by University of Edinburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284191
First Posted: November 5, 2014
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
  Purpose
This study aims to investigate the effect of early CTCA in patients with suspected or confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention. The primary objective will be to investigate the effect of the intervention on the proportion of patients with all-cause death or recurrent non-fatal type 1 or type 4b myocardial infarction (MI) at one year.

Condition Intervention
Acute Coronary Syndrome Radiation: CT Coronary Angiogram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Role of Early CT Coronary Angiography in the Evaluation, Intervention and Outcome of Patients Presenting to the Emergency Department With Suspected or Confirmed Acute Coronary Syndrome.

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • The primary end-point will be all-cause death or recurrent non-fatal type type 1 and 4b myocardial infarction at one year, measured as time to first such event. [ Time Frame: 1 year ]
    Myocardial infarction will be defined according to the most recent Universal Definition [Thygesen K, 2012] and will be adjudicated by two independent cardiologists blinded to the intervention and will be adjudicated by two independent cardiologists blinded to the intervention.


Secondary Outcome Measures:
  • Hospital length of stay [ Time Frame: 1 year ]
  • Coronary care length of stay [ Time Frame: 1 year ]
  • Proportion of patients receiving invasive coronary angiography during index hospitalisation [ Time Frame: 1 year ]
  • Proportion of patients receiving coronary revascularisation during index hospitalisation [ Time Frame: 1 year ]
  • Proportion of patients receiving subsequent unplanned coronary revascularisation after index hospitalisation within 12 months [ Time Frame: 1 year ]
  • Proportion of patients in CTCA arm receiving invasive coronary angiography despite <50% stenosis on CTCA [ Time Frame: 1 year ]
  • Proportion of patients assigned to CTCA with normal or mild non-obstructive disease [ Time Frame: 1 year ]
  • Proportion of patients prescribed ACS therapies and/or discharged on secondary prevention treatment during index hospitalisation [ Time Frame: 1 year ]
  • Proportion of patients discharged on prevention treatment or have alteration in dosage of prevention treatment during index hospitalisation [ Time Frame: 1 year ]
  • Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months [ Time Frame: 1 year ]
  • Patient symptoms (up to 12 months) ROSE Questionnaire [ Time Frame: 1 year ]
    Patient symptoms measured by ROSE questionnaire

  • Patient quality of life (up to 12 months) EQ-5D-5L questionnaire [ Time Frame: 1 year ]
    Quality of life measured by EQ-5D-5L questionnaire

  • NHS resource utilisation [ Time Frame: 1 year ]
  • Patient satisfaction with care questionnaire [ Time Frame: 1 year ]
    Participant questionnaire (11 questions) asking their viewpoint on the care they received during their baseline admission.

  • Clinician certainty of presenting diagnosis after CTCA [ Time Frame: 1 year ]
  • Proportion of patients with allergy/anaphylaxis/acute kidney injury [ Time Frame: 1 year ]
    Safety assessment

  • Proportion of patients with alternative diagnoses that relate to a presentation on CTCA e.g. aortic dissection or incidental but potentially concerning e.g. malignancy or pulmonary embolus [ Time Frame: 1 year ]
    Safety assessment

  • Proportion of patients with incidental finding but potentially concerning on CTCA e.g. malignancy or pulmonary nodules [ Time Frame: 1 year ]
  • Total average radiation exposure from CTCA in the intervention arm during index hospitalisation [ Time Frame: 1 year ]
    Safety assessment

  • Cost effectiveness [ Time Frame: 1 year ]
    Estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.


Estimated Enrollment: 2500
Study Start Date: January 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CT Coronary Angiogram
CT Coronary Angiogram plus standard care
Radiation: CT Coronary Angiogram
Completion of a CT Coronary Angiogram
No Intervention: Standard Care
Standard care only

Detailed Description:

DESIGN: Open parallel group randomised controlled trial of early computed tomography coronary angiography (CTCA) in patients presenting with suspected/confirmed acute coronary syndrome (ACS) to Emergency Departments (ED) and Medical Assessment Units.

SETTING: 30 EDs, radiology, cardiology and acute medical services in tertiary/district general National Health Service (NHS) hospitals.

TARGET POPULATION

Inclusion Criteria: Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of: ECG abnormalities e.g. ST segment depression >0.5 mm; History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records); Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' or myocardial infarction (NB troponin assays will vary from site to site; local laboratory reference standards will be used). Exclusion Criteria: 1.Signs, symptoms, or investigations supporting high-risk ACS: ST elevation MI; ACS with signs or symptoms of acute heart failure or circulatory shock; Crescendo episodes of typical anginal pain; Marked or dynamic ECG changes e.g. ST depression of >3 mm; Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment. 2. Patient inability to undergo CT: Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min); Contrast allergy; Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy; Inability to breath hold; Atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade). 3. Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease, or patient had either investigation within the last 5 years and the result was normal. 4.Previous recruitment to the trial; 5.Known pregnancy or currently breast feeding; 6. Inability to consent; 7.Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status; 8.Prisoners HEALTH TECHNOLOGIES BEING ASSESSED: Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.

MEASUREMENT OF COSTS/OUTCOMES: Primary end-point will be one-year all-cause death or recurrent type 1 MI. Secondary endpoints: 1. Hospital stay, coronary care stay; 2. Proportion of patients receiving invasive coronary angiography during index hospitalisation; 3. Proportion of patients receiving coronary revascularisation during index hospitalisation; 4. Proportion of patients receiving subsequent unplanned coronary revascularisation after index hospitalisation; 5. Proportion of patients receiving invasive coronary angiography despite no significant lesion on CTCA; 6. Proportion of patients prescribed ACS therapies and/or discharged on secondary prevention treatment during index hospitalisation; 7. Rehospitalisation/presentation with chest pain within 12 months; 8. Patient symptoms and quality of life up to 12 months; 9. NHS resource utilisation; 10. Patient satisfaction. Safety: 1. Proportion of patients with allergy/anaphylaxis/acute kidney injury; 2. Proportion of patients with alternative diagnoses e.g. aortic dissection or incidental but potentially concerning e.g. malignancy; 3. Total radiation exposure in each arm. Cost effectiveness: estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.

SAMPLE SIZE: 2,500 patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of:

  • ECG abnormalities e.g. ST segment depression >0.5 mm;
  • History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records);
  • Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' or myocardial infarction (NB troponin assays will vary from site to site; local laboratory reference standards will be used).

EXCLUSION CRITERIA

  • Signs, symptoms, or investigations supporting high-risk ACS:

    • ST elevation MI;
    • ACS with signs or symptoms of acute heart failure or circulatory shock;
    • Crescendo episodes of typical anginal pain;
    • Marked or dynamic ECG changes e.g. ST depression of >3 mm
    • Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment.
  • Patient inability to undergo CT:

    • Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min);
    • Contrast allergy;
    • Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy ;
    • Inability to breath hold;
    • Atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade).
  • Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease, or patient had either investigation within the last 5 years and the result was normal.
  • Previous recruitment to the trial;
  • Known pregnancy or currently breast feeding;
  • Inability to consent;
  • Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status;
  • Prisoners
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284191


Contacts
Contact: Kat Oatey 0131 651 9913 k.oatey@ed.ac.uk
Contact: Rachel O'Brien 0131 242 3867 rachel.o'brien@nhslothian.scot.nhs.uk

Locations
United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust Recruiting
Basildon, United Kingdom
Contact: Jason Dungu         
Ulster Hospital Recruiting
Belfast, United Kingdom
Contact: Patrick Donnelly         
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Contact: Ben Holloway         
The Royal Bournemouth and Christchurch Hospital Recruiting
Bournemouth, United Kingdom
Contact: Jehangir Din         
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom
Contact: Sudantha Bulugahapitiya         
Russells Hall Hospital Recruiting
Dudley, United Kingdom
Contact: Robert Huggett         
Ninewells Hospital Recruiting
Dundee, United Kingdom
Contact: John Irving         
Royal Infirmary Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Alasdair Gray    0131 242 1340    alasdair.gray@nhslothian.scot.nhs.uk   
Principal Investigator: Alasdair Gray         
Glasgow Royal Infirmary Terminated
Glasgow, United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Contact: Claire McGroarty         
Raigmore Hospital Recruiting
Inverness, United Kingdom
Contact: Jonathan Watt         
Jersey General Hospital Recruiting
Jersey, United Kingdom
Contact: Andrew Mitchell         
Contact: Jessica Langtree         
Victoria Hospital Recruiting
Kirkcaldy, United Kingdom
Contact: Andrew Kinnon         
Leeds General Infirmary Recruiting
Leeds, United Kingdom
Contact: Abdel-Rahman Saif-El-Dean         
University Hospital Lewisham Recruiting
Lewisham, United Kingdom
Contact: Khalid Alfakih         
Royal London Hospital Recruiting
London, United Kingdom
Contact: Tim Harris         
St. Thomas' Hospital Recruiting
London, United Kingdom
Contact: Ronak Ranjani         
University Hospital North Tees Recruiting
London, United Kingdom
Contact: Justin Carter         
Whipps Cross Hospital Recruiting
London, United Kingdom
Contact: Tim Harris         
Luton & Dunstable Hospital Recruiting
Luton, United Kingdom
Contact: Christopher Travill         
Borders General Hospital Recruiting
Melrose, United Kingdom
Contact: Anne Scott         
Milton Keynes University Hospital NHS Foundation Trust Recruiting
Milton Keynes, United Kingdom
Contact: Atilla Kardos         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom
Contact: Anna Beattie         
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: Carl Roobottom         
Queen Alexandra Hospital Recruiting
Portsmouth, United Kingdom
Contact: Chris Vorwerk         
Royal Berkshire NHS Foundation Trust Recruiting
Reading, United Kingdom
Contact: Liza Keating         
East Surrey Hospital Terminated
Redhill, United Kingdom
Rotherham Hospital Recruiting
Rotherham, United Kingdom
Contact: Rangasamy Muthusamy         
Sandwell General Hospital Recruiting
Sandwell, United Kingdom
Contact: Derek Connolly         
Northern General Hospital Recruiting
Sheffield, United Kingdom
Contact: Steve Goodacre         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom
Contact: Nick Curzen         
University Hospitals of the Midlands Recruiting
Stoke, United Kingdom
Contact: Hefin Jones         
Torbay Hospital Recruiting
Torquay, United Kingdom
Contact: Dirk Felmeden         
New Cross Hospital Recruiting
Wolverhampton, United Kingdom
Contact: Elisa McAlindon         
Worcestershire Royal Hospital Recruiting
Worcester, United Kingdom
Contact: Will Roberts         
Wrexham Maelor Hospital Recruiting
Wrexham, United Kingdom
Contact: Ash Basu         
University Hospital South Manchester Recruiting
Wythenshawe, United Kingdom
Contact: Matthias Schmitt         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Alasdair J Gray NHS Lothian
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02284191     History of Changes
Other Study ID Numbers: RAPID-CTCA-2014
First Submitted: October 6, 2014
First Posted: November 5, 2014
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by University of Edinburgh:
Radiology
Acute Medicine
Emergency Medicine
Cardiology

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases