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RAPID-CTCA

Start date:
March 2015
End date:
September 2017
Co-ordinated by:
EMERGE

EMERGE are delighted to be leading the RAPID-CTCA trial with the Edinburgh Clinical Trials Unit (ECTU). This is a pragmatic study aiming to recruit 2,500 adult patients admitted with suspected or confirmed Acute Coronary Syndrome.

The study is taking place throughout the UK and we are still enlisting new sites. Recruitment will run for 30 months beginning March 2015.

This website provides some key information and contacts for participating sites, including recruitment figures and is a source of information for medical professionals who may be interested in the trial.

Trial Summary

This is a synopsis of the RAPID-CTCA trial based upon the current version of the trial Protocol, version 4, 23-May-2016, which may be subject to change.

The trial aims to evaluate 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.

ISRCTN No:

ISRCTN19102565

Clinical Trials.gov ID:

NCT02284191

UK Portfolio Adoption:

The trial is funded by the NIHR HTA. The trial has been adopted onto the NIHR portfolio and therefore is eligible to receive CRN support.

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, acute medical services, radiology and cardiology departments in tertiary/district general NHS hospitals.

Target population:
Patients with suspected or confirmed ACS

Health technologies being assessed:
Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.

Primary Endpoint:
The primary end-point will be all-cause death or recurrent non-fatal type 1 or type 4b MI at one year and time to first such event.

Current Participating Centres:

Royal Infirmary of Edinburgh – Professor Alasdair Gray

Sheffield Teaching Hospitals Trust – Professor Steve Goodacre

Derriford Hospital, Plymouth – Professor Carl Roobottom and Surgeon Captain Jason Smith

Torbay Hospital, Torquay – Dr Dirk Felmeden

Victoria Hospital, Kirkcaldy – Dr Andy Kinnon

Royal Berkshire Hospital, Reading – Dr Liza Keating

Russells Hall, Hospital, Dudley – Dr Robert Huggett

Royal Bournemouth & Christchurch Hospitals – Dr Jehangir Din

Borders General Hospital – Dr Anne Scott

Royal Victoria Infirmary, Newcastle – Dr Anna Beattie

Lewisham Hospital – Dr Khaled Alfakih

Jersey General Hospital – Dr Andrew Mitchell

Bradford Teaching Hospital – Dr Sudantha Bulugahapitiya

Glasgow Royal Infirmary – Dr Adrian Brady and Dr David Lowe

Sandwell Hospital – Dr Derek Connolly

Rotherham NHS Trust – Dr Rangasamy Muthusamy

Milton Keynes Hospital – Dr Atilla Kardos and Dr. John Northfield

University Hospital Southampton – Professor Nick Curzen

Royal Stoke University Hospital – Dr Hefin Jones

East Surrey Hospital – Dr Ansuman Saha

Guys & St Thomas NHS Foundation Trust – Dr Ronak Rajani

Luton & Dunstable Hospital – Dr Christopher Travill

Leeds Teaching Hospitals NHS Trust – Dr Saif-El-Dean Abdel-Rahman

Worcestershire Acute Hospitals NHS Trust – Dr Will Roberts

Queen Elizabeth Hospital, Birmingham – Dr Ben Holloway

Royal London Hospital – Professor Tim Harris

Whipps Cross Hospital – Professor Tim Harris

Ninewells Hospital – Dr John Irving

University Hospital of North Tees – Dr Justin Carter

Queen Alexandra, Portsmouth – Dr Chris Vorweck

Wrexham Mealor Hospital – Dr Ash Basu

New Cross Hospital, Woverhampton – Dr Elsa McAlindon

Basildon and Thurrock University Hospital – Dr. Jason Dungu

University hospital of South Manchester – Dr. Matthias Schmitt

Ulster Hospital – Dr. Patrick Donnelly

Raigmore Hospital, Inverness – Dr. Jonathon Watt

Queen Elizabeth University Hospital, Glasgow – Dr. Claire Mcgroarty

 

 Eligibility 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

  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.
  1. 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).
  1. 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.
  1. Previous recruitment to the trial;
  1. Known pregnancy or currently breast feeding;
  1. Inability to consent;
  2.  Further investigation for ACS would not in the patient’s interest, due to limited life expectancy, quality of life or functional status;
  3. Prisoners

 

 

Chief Investigator

Professor Alasdair Gray

Director of EMERGE & Consultant in Emergency Medicine

Research Team

Kat Oatey

ECTU Trial Manager

Rachel O'Brien

Lead Research Nurse

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