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

Sponsor

AJAY YERRAMASU (Other)

Overall Status

Unknown status

CT.gov ID

NCT01464203

Collaborator

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

600

Enrollment

Locations

Arms

33.9

Duration (Months)

200

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: CT coronary angiography Other: Standard of Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cost of diagnosis [one year]

Secondary Outcome Measures

Diagnostic Accuracy of CT coronary angiography [one year]
Diagnostic accuracy of CT coronary angiography in detecting >50% coronary stenosis, using invasive coronary angiography as reference standard.
Quality of life [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
Number of normal invasive coronary angiograms [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
Number of invasive coronary angiograms not followed by coronary revascularization [one year]
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 [1 year]
Prognostic value of CT coronary angiography in predicting major adverse cardiovascular events over a median follow-up period of 1 year.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Barnet and Chase Farm Hospitals NHS Trust	Barnet	Hertfordshire	United Kingdom	EN5 3DJ
2	Royal Free Hospital NHS Trust	London		United Kingdom	NW3 2QG
3	Clinical Imaging and Research Centre, Wellington Hospital	London		United Kingdom	NW8 9LE