Role of Cardiac CT in Rapid Access Chest Pain Clinics (RADICAL)

NCT01464203 | Unknown DMC

• 1 other identifier: RADICAL Trial
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

Heart disease remains the most common cause of death in the UK. Chest pain is often the first presenting symptom in patients with heart disease, and may be a warning signal prior to a heart attack or death. The diagnosis based on symptoms alone however is unreliable and further testing is almost always necessary. Rapid access chest pain clinics (RACPCs) are able to expedite the assessment of such patients. The principal investigation used is an exercise stress electrocardiogram (s-ECG). Although simple, cheap, and convenient, the s-ECG is often inaccurate; missing the diagnosis or falsely suggesting the diagnosis. This can happen in as many as 25% of patients, resulting in a delay in treatment or unnecessary further investigation. CT Angiography (CTA) is a novel non-invasive technique where the coronary arteries can be visualised by Computerised Tomography. In previous studies it shows a high degree of correlation with invasive angiography, with a high accuracy for the diagnosis of obstructive coronary artery disease. However, the technique is relatively new, and its full role is yet to be defined in the clinical setting of a chest pain clinic. The investigators do not at present have any information as to whether it is able to speed up the diagnosis, reduce the need for other tests, and therefore also costs. In this trial, the investigators aim to examine the accuracy and cost effectiveness of CTA in patients with suspected cardiac chest pain presenting to a chest pain clinic, when compared to the more established techniques like s-ECG, myocardial perfusion scanning and coronary angiography. The study will enable us to establish the optimal and most cost effective strategy for investigation of patients presenting to chest pain clinics.

Conditions

Coronary Artery Disease

Keywords

Computed tomographic coronary angiography; multi-slice CT; angina; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cost of diagnosis

  one year

Secondary Outcomes (5)

• Diagnostic Accuracy of CT coronary angiography

  one year

• Quality of life

  one year

• Number of normal invasive coronary angiograms

  one year

• Number of invasive coronary angiograms not followed by coronary revascularization

  one year

• Prognostic value of CT coronary angiography

  1 year

Study Arms (2)

CT coronary angiography

EXPERIMENTAL

Patients in this arm will undergo CT coronary angiography to assess the patency of coronary arteries and their clinical management will be decided by the results of CT coronary angiography.

Other: CT coronary angiography

Control Arm

ACTIVE COMPARATOR

Patients in this arm will receive the "standard of care" (SoC). They will undergo either coronary angiography, myocardial perfusion scan or stress echocardiography as decided by the physician in charge, depending on the local availability of individual investigations and the patient's clinical scenario.

Other: Standard of Care

Interventions

CT coronary angiography OTHER

CT coronary angiography: This allows two distinct assessments of the coronary arteries to be made: * coronary calcium scan, which is a 30 second, low-radiation scan that allows reproducible quantification of the amount of calcium in the coronary arteries to be made. * contrast enhanced CT coronary angiogram. This is a quick, non-invasive scan to assess the patency of coronary arteries.

CT coronary angiography

Standard of Care OTHER

The management of patients in this group is according to the NHS protocol and is not altered by their participation in the trial. The choice of diagnostic investigation for CAD is determined by the patient's clinical scenario and the availability of different diagnostic modalities in the recruiting hospital.

Control Arm

Eligibility Criteria

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

You may qualify if:

• chest pain or shortness of breath suspected to be due to coronary artery disease

You may not qualify if:

• Age \< 40 years
• Pregnancy
• Serum Creatinine \> 150 mmol/L or eGFR \< 40
• Established or suspected acute coronary syndrome
• Previous history of PTCA
• Atrial Fibrillation
• History of allergy to iodinated contrast media

Sponsors & Collaborators

• AJAY YERRAMASU: lead
• Wellington Hospital: collaborator
• Barnet and Chase Farm Hospitals NHS Trust: collaborator
• Chase Farm Hospital: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (3)

Barnet and Chase Farm Hospitals NHS Trust

Barnet, Hertfordshire, EN5 3DJ, United Kingdom

RECRUITING

Royal Free Hospital NHS Trust

London, London, NW3 2QG, United Kingdom

RECRUITING

Clinical Imaging and Research Centre, Wellington Hospital

London, London, NW8 9LE, United Kingdom

RECRUITING

Related Publications (2)

• Yerramasu A, Venuraju S, Lahiri A. Evolving role of cardiac CT in the diagnosis of coronary artery disease. Postgrad Med J. 2011 Mar;87(1025):180-8. doi: 10.1136/pgmj.2009.093815. Epub 2010 Aug 5.

  PMID: 20693150 BACKGROUND

• Yerramasu A, Lahiri A, Venuraju S, Dumo A, Lipkin D, Underwood SR, Rakhit RD, Patel DJ. Diagnostic role of coronary calcium scoring in the rapid access chest pain clinic: prospective evaluation of NICE guidance. Eur Heart J Cardiovasc Imaging. 2014 Aug;15(8):886-92. doi: 10.1093/ehjci/jeu011. Epub 2014 Feb 9.

  PMID: 24513880 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Deven Patel, MBBch, FRCP

  Barnet Hospital, Wellhouse Lane, Barnet, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AJAY YERRAMASU, MBBS, MRCP

CONTACT

07816674938; dryerramasu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: October 15, 2011
• First Posted: November 3, 2011
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 3, 2011

Record last verified: 2011-10

Locations

GB (3)