Clinical trial NCT01464203: Role of Cardiac CT in Rapid Access Chest Pain Clinics (RADICAL)
Official title: Randomized Controlled Trial to Evaluate the Cost and Clinical Effectiveness of CT Coronary Angiography in Patients With Stable Angina Pectoris (RADICAL Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Computed tomographic coronary angiography
multi-slice CT
angina
cost-effectiveness
Lead sponsor: Wellington Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Wellington Hospital
name: Barnet and Chase Farm Hospitals NHS Trust
name: Chase Farm Hospital
name: Royal Free Hospital NHS Foundation Trust
First posted: 2011-11-03
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Cost of diagnosis
timeFrame: one year
Secondary outcomes:
measure: Diagnostic Accuracy of CT coronary angiography
timeFrame: one year
measure: Quality of life
timeFrame: one year
measure: Number of normal invasive coronary angiograms
timeFrame: one year
measure: Number of invasive coronary angiograms not followed by coronary revascularization
timeFrame: one year
measure: Prognostic value of CT coronary angiography
timeFrame: 1 year
Other outcomes:
Locations:
city: Barnet
country: United Kingdom
facility: Barnet and Chase Farm Hospitals NHS Trust
state: Hertfordshire
city: London
country: United Kingdom
facility: Royal Free Hospital NHS Trust
city: London
country: United Kingdom
facility: Clinical Imaging and Research Centre, Wellington Hospital
Study officials:
affiliation: Barnet Hospital, Wellhouse Lane, Barnet, UK
name: Deven Patel, MBBch, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.