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

October 31, 2011 updated by: AJAY YERRAMASU

Randomized Controlled Trial to Evaluate the Cost and Clinical Effectiveness of CT Coronary Angiography in Patients With Stable Angina Pectoris (RADICAL Trial)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study Objectives:

  • To assess the diagnostic accuracy and cost effectiveness of non-invasive coronary angiogram by Cardiac CT in the diagnosis of coronary artery disease in patients with angina, in the setting of Rapid Access Chest Pain clinics
  • To formulate an optimal diagnostic algorithm in terms of accuracy and cost effectiveness for diagnosis of CAD in patients with chest pain.

Study Setting:

- Rapid Access Chest Pain clinics in 3 NHS hospitals (Barnet, Chase Farm and the Royal Free hospitals)

Target Population:

- Patients with new onset, stable exertional angina presenting to Rapid Access Chest Pain clinics.

Study Design and Methodology:

This trial is designed as a prospective randomized case - control study. 600 patients who meet the study criteria will be recruited from Rapid Access Chest Pain Clinics. The patients will be randomized into 2 cohorts (study and control) of 300 each. All patients will undergo stress - ECG at the referring hospital. Patients in the control group will receive the 'standard clinical care'. Their management is not altered by their inclusion in the trial. All patients in the study group will undergo CT coronary Angiography at the Clinical Imaging and Research Centre based at the Wellington Hospital. Patients with obstructive coronary artery disease (defined as >50% stenosis in left main coronary artery or >70% stenosis in one of the other major epicardial coronary arteries) will be referred for invasive coronary angiography +/- revascularization. Patients with intermediate (50-70%) coronary stenosis will be referred to myocardial perfusion scan (MPS). Patients with significant reversible ischemia on MPS will be referred to invasive coronary angiography +/- revascularization. Patients who do not have evidence of significant reversible ischemia on MPS and those with <50% stenosis on CT coronary angiogram will be discharged on appropriate medications. All patients will be followed up for 12 months after recruitment. Information will be gathered regarding clinical events (non-fatal/fatal MI, acute coronary syndrome, hospitalization, emergency/elective revascularization) and quality of life as per SF-36 questionnaire. All the diagnostic and therapeutic procedures underwent by each patient in both cohorts will be recorded. The cost-effectiveness of each CT coronary angiography will be calculated by using the NHS reference costs.

Primary outcome measure: The total cost of diagnosis for current diagnostic strategy being used in the Rapid Access Chest Pain Clinics and a new strategy involving the use of CT coronary angiography in the investigation of patients with angina.

Secondary outcome measures:

  • Diagnostic Accuracy of CT coronary angiography
  • Prognostic value of CT coronary angiography
  • Number of normal angiograms in each cohort
  • Number of angiograms not followed by revascularization in each cohort
  • Quality of life as assessed by SF-36 Questionnaire

For calculating cost effectiveness, NHS reference costs will be used. Thus, the costs and benefits will be considered from the NHS perspective

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, NW8 9LE
        • Recruiting
        • Clinical Imaging and Research Centre, Wellington Hospital
        • Contact:
        • Contact:
    • Hertfordshire
      • Barnet, Hertfordshire, United Kingdom, EN5 3DJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CT coronary angiography
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

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.
ACTIVE_COMPARATOR: Control Arm
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost of diagnosis
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of CT coronary angiography
Time Frame: one year
Diagnostic accuracy of CT coronary angiography in detecting >50% coronary stenosis, using invasive coronary angiography as reference standard.
one year
Quality of life
Time Frame: one year
quality of life is measured in the study and control subjects after a median follow-up period of one year, using SF-36 questionnaire
one year
Number of normal invasive coronary angiograms
Time Frame: one year
Number of invasive coronary angiograms that show either normal coronary arteries or non-obstructive coronary disease (<50% coronary stenosis) will be measured and compared between study and control groups
one year
Number of invasive coronary angiograms not followed by coronary revascularization
Time Frame: one year
Number of invasive coronary angiograms that are not followed by revascularization will measured and compared between study and control groups.
one year
Prognostic value of CT coronary angiography
Time Frame: 1 year
Prognostic value of CT coronary angiography in predicting major adverse cardiovascular events over a median follow-up period of 1 year.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AJAY YERRAMASU

Collaborators

Royal Free Hospital NHS Foundation Trust
Barnet and Chase Farm Hospitals NHS Trust
Wellington Hospital, London, UK
Chase Farm Hospital

Investigators

  • Principal Investigator: Deven Patel, MBBch, FRCP, Barnet Hospital, Wellhouse Lane, Barnet, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

October 15, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (ESTIMATE)

November 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADICAL Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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