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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Wellington Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wellington Hospital, London, UK
Barnet and Chase Farm Hospitals NHS Trust
Chase Farm Hospital, The Ridgeway, Enfield, EN2 8JL, UK
Royal Free Hospital NHS Foundation Trust
Information provided by (Responsible Party):
AJAY YERRAMASU, Wellington Hospital
ClinicalTrials.gov Identifier:
NCT01464203
First received: October 15, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: CT coronary angiography
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial to Evaluate the Cost and Clinical Effectiveness of CT Coronary Angiography in Patients With Stable Angina Pectoris (RADICAL Trial)

Resource links provided by NLM:


Further study details as provided by Wellington Hospital:

Primary Outcome Measures:
  • Cost of diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic Accuracy of CT coronary angiography [ Time Frame: one year ] [ Designated as safety issue: No ]
    Diagnostic accuracy of CT coronary angiography in detecting >50% coronary stenosis, using invasive coronary angiography as reference standard.

  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    quality of life is measured in the study and control subjects after a median follow-up period of one year, using SF-36 questionnaire

  • Number of normal invasive coronary angiograms [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

  • Number of invasive coronary angiograms not followed by coronary revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of invasive coronary angiograms that are not followed by revascularization will measured and compared between study and control groups.

  • Prognostic value of CT coronary angiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Prognostic value of CT coronary angiography in predicting major adverse cardiovascular events over a median follow-up period of 1 year.


Estimated Enrollment: 600
Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464203

Contacts
Contact: AJAY YERRAMASU, MBBS, MRCP 07816674938 dryerramasu@yahoo.com

Locations
United Kingdom
Barnet and Chase Farm Hospitals NHS Trust Recruiting
Barnet, Hertfordshire, United Kingdom, EN5 3DJ
Contact: Deven Patel, MBBCh, MRCP       deven.patel@bcf.nhs.uk   
Contact: Alain Dumo, BSc       alain.dumo@bcf.nhs.uk   
Clinical Imaging and Research Centre, Wellington Hospital Recruiting
London, United Kingdom, NW8 9LE
Contact: AJAY YERRAMASU, MBBS, MRCP    0044-781667-4938    dryerramasu@yahoo.com   
Contact: Shreenidhi Venuraju, MBBS, MRCP    0044-207-4835085    dryerramasu@yahoo.com   
Royal Free Hospital NHS Trust Recruiting
London, United Kingdom, NW3 2QG
Contact: Roby Rakhit, MBBCh, MD, MRCP       roby.rakhit@royalfree.nhs.uk   
Sponsors and Collaborators
AJAY YERRAMASU
Wellington Hospital, London, UK
Barnet and Chase Farm Hospitals NHS Trust
Chase Farm Hospital, The Ridgeway, Enfield, EN2 8JL, UK
Royal Free Hospital NHS Foundation Trust
Investigators
Principal Investigator: Deven Patel, MBBch, FRCP Barnet Hospital, Wellhouse Lane, Barnet, UK
  More Information

Publications:
Responsible Party: AJAY YERRAMASU, Clinical Research Fellow, Wellington Hospital
ClinicalTrials.gov Identifier: NCT01464203     History of Changes
Other Study ID Numbers: RADICAL Trial
Study First Received: October 15, 2011
Last Updated: October 31, 2011
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Wellington Hospital:
Computed tomographic coronary angiography
multi-slice CT
angina
cost-effectiveness

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014