Coronary Artery DiseaseRADICALNCT01464203
Role of Cardiac CT in Rapid Access Chest Pain Clinics (RADICAL)
A study testing CT coronary angiography in people with Coronary Artery Disease, run by AJAY YERRAMASU at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chest pain or shortness of breath suspected to be due to coronary artery disease
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Barnet and Chase Farm Hospitals NHS Trust
Barnet, Hertfordshire, EN5 3DJ
Deven Patel, MBBCh, MRCP, deven.patel@bcf.nhs.uk
Alain Dumo, BSc, alain.dumo@bcf.nhs.uk
- Recruiting
Royal Free Hospital NHS Trust
London, London, NW3 2QG
Roby Rakhit, MBBCh, MD, MRCP, roby.rakhit@royalfree.nhs.uk
- Recruiting
Clinical Imaging and Research Centre, Wellington Hospital
London, London, NW8 9LE
AJAY YERRAMASU, MBBS, MRCP, 0044-781667-4938, dryerramasu@yahoo.com
Shreenidhi Venuraju, MBBS, MRCP, 0044-207-4835085, dryerramasu@yahoo.com
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- CT coronary angiography, Standard of Care
- Keywords
- Computed tomographic coronary angiography, multi-slice CT, angina, cost-effectiveness
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT coronary angiographyOther
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of diagnosis
Measured: one year
Secondary outcomes (5)
Diagnostic Accuracy of CT coronary angiography
Diagnostic accuracy of CT coronary angiography in detecting >50% coronary stenosis, using invasive coronary angiography as reference standard.
Measured: one year
Quality of life
quality of life is measured in the study and control subjects after a median follow-up period of one year, using SF-36 questionnaire
Measured: one year
Number of normal invasive coronary angiograms
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
Measured: one year
Number of invasive coronary angiograms not followed by coronary revascularization
Number of invasive coronary angiograms that are not followed by revascularization will measured and compared between study and control groups.
Measured: one year
Prognostic value of CT coronary angiography
Prognostic value of CT coronary angiography in predicting major adverse cardiovascular events over a median follow-up period of 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AJAY YERRAMASU
- Sponsor type
- Other government
- Collaborators
- Wellington Hospital, Barnet and Chase Farm Hospitals NHS Trust, Chase Farm Hospital, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor-investigator, AJAY YERRAMASU, Wellington Hospital
- Investigators
- Deven Patel, MBBch, FRCP, Principal investigator, Barnet Hospital, Wellhouse Lane, Barnet, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464203
- Sponsor's protocol ID
- RADICAL Trial
- Acronym
- RADICAL
- Status last verified
- Oct 2011
- First submitted
- 15 Oct 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20693150Yerramasu 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.
PubMed 24513880
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Cost and Clinical Effectiveness of CT Coronary Angiography in Patients With Stable Angina Pectoris (RADICAL Trial)
- ClinicalTrials.gov ID
- NCT01464203
- Acronym / sponsor ID
- RADICAL / RADICAL Trial
- Conditions
- Coronary Artery Disease
- Keywords
- Computed tomographic coronary angiography, multi-slice CT, angina, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AJAY YERRAMASUOther government
- Collaborators
- Wellington Hospital, Barnet and Chase Farm Hospitals NHS Trust, Chase Farm Hospital, Royal Free Hospital NHS Foundation Trust
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT coronary angiography | Experimental | Other: CT coronary angiographyPatients 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. |
| Control Arm | Active comparator | Other: Standard of CarePatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chest pain or shortness of breath suspected to be due to coronary artery disease
Key exclusion criteria (7 listed)
- Age < 40 years
- Pregnancy
- Serum Creatinine > 150 mmol/L or eGFR < 40
- Established or suspected acute coronary syndrome
- Previous history of PTCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT coronary angiographyCT 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. | Other | CT coronary angiography |
| Standard of CareThe 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. | Other | Control Arm |
Primary outcome
Cost of diagnosis
Time frame: one year
5 secondary outcomes
Diagnostic Accuracy of CT coronary angiography
Time frame: one year
Quality of life
Time frame: one year
Number of normal invasive coronary angiograms
Time frame: one year
Number of invasive coronary angiograms not followed by coronary revascularization
Time frame: one year
Prognostic value of CT coronary angiography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
- Background: PubMed 20693150Yerramasu 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.
- Derived from this study: PubMed 24513880Yerramasu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deven Patel, MBBch, FRCP principal investigator
Barnet Hospital, Wellhouse Lane, Barnet, UK
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT coronary angiography in people with Coronary Artery Disease, run by AJAY YERRAMASU at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AJAY YERRAMASU, MBBS, MRCP (07816674938, dryerramasu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of diagnosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464203, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2011.