Coronary DiseaseNCT01660594
CT Calcium Scoring in Suspected Stable Angina
An observational study of Coronary Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- CT calcium scoring
- How many people
- 705 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Dec 2011
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who presented to our chest pain clinic between October 2003 to March 2010 with stable (non-acute) chest pain and assessed with history, physical examination, cardiovascular risk factors, chest X-ray, 12-lead resting ECG and exercise ECG.
Who may be able to join
- non-acute chest pain
- those who underwent CT calcium scoring
- availability of all relevant risk factor information
Who cannot join
- previous coronary disease i.e., myocardial infarction or revascularization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of CT Coronary Artery Calcium Scoring With Traditional Assessment in Patients Presenting to the Rapid Access Chest Pain Clinic With Non-acute Chest Pain and Its Prognostic Value
Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.
At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.
Read the detailed description
The study seeks to determine the usefulness of CT calcium scoring (CTCS) in patients presenting with non-acute chest pain to the rapid access chest pain clinic (RACPC) and compare it with the traditional assessment in predicting significant CAD and outcome with respect to non-fatal MI or death. The clinical, diagnostic, and follow-up data of patients in last 7 years since CTCS has been performed in the hospital would be retrospectively analysed for the purpose.
Background Patients with chest pain (excluding that of sudden onset) are routinely referred by the GPs to the RACPC centres in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. At our institution, we have also been performing CTCS in men more than 40 and women more than 50 years of age since 2003. Recent NICE guidance1 recommends that patients with low pre-test probability (10-30%) of significant coronary artery disease (CAD) have a CT calcium scoring scan and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.
This study would enable us to compare and determine the value of CTCS in patients with non-acute chest pain in predicting significant CAD and safety of absent coronary artery calcification.
Rationale for Study
- To determine if CT coronary calcium scoring adds any value to the existing clinical assessment and exercise ECG. This is not well established in patients presenting with non-acute chest pain to the rapid access chest pain clinics.
- The study would help in determining if absence of calcification on CT can be considered to have low likelihood of significant coronary artery disease and a good cardiovascular outcome over the period of follow-up. Both these issues are currently controversial in the literature in this group of patients.
STUDY OBJECTIVES
Primary Objective To determine the prognostic value of CT coronary calcium scoring in patients with non-acute chest pain for non-fatal MI and death, and compare with traditional assessment including exercise ECG.
Secondary Objectives To determine how CT coronary calcium scoring compare with traditional assessment including exercise ECG in predicting significant coronary artery disease in patients presenting with non-acute chest pain.
METHODOLOGY Design This is a retrospective cross-sectional study involving analysis of patients' clinical, diagnostic, and management data from hospital records and follow-up questionnaires for outcome. The study does not require any new diagnostic, therapeutic, or interventional procedure.
Data of patients who have presented to the chest pain clinic since October 2003 would be collected from hospital records for:
- Age, sex, type of chest pain, and risk factors. These would be used to calculate the pre-test probability of significant coronary artery disease (CAD) using Duke's score.
- Results of exercise ECG where performed.
- Results of CT calcium scoring.
- Results of other non-invasive investigations such as stress imaging and CT coronary angiography where performed.
- Results of invasive coronary angiography where performed. Patients with >70% diameter stenosis or those who underwent percutaneous stent insertion (PCI) or bypass surgery would be considered to have significant CAD.
For those patients who do not undergo any PCI or surgery as a result of above evaluation, we will try to find out if they have subsequently suffered any heart attack or died. This would again be performed through hospital records and if not available, through questionnaires send to the patients and/or their GPs as part of standard clinical care.
- Conditions
- Coronary Disease
- Being tested
- CT calcium scoring
- Keywords
- coronary disease, tomography, x-ray computed, calcium, exercise test
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT calcium scoringOther
CT Calcium scoring was performed in the patients as an imaging test in addition to the traditional assessment on the same day of patients attending the chest pain clinic on the first visit. This was performed with standard protocol and the absolute calcium score was calculated.
| Study group | Role | What they receive |
|---|---|---|
| Stable chest pain | All patients presenting with stable chest pain and referred by their general practitioners to the chest pain clinic in the hospital who had CT calcium scoring performed besides standard assessment. Receives: Other: CT calcium scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 7 years
Secondary outcomes (1)
Non-fatal myocardial infarction
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660594
- Sponsor's protocol ID
- 11/LO/1693
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skinner JS, Smeeth L, Kendall JM, Adams PC, Timmis A; Chest Pain Guideline Development Group. NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart. 2010 Jun;96(12):974-8. doi: 10.1136/hrt.2009.190066. No abstract available.
PubMed 20538674
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CT Coronary Artery Calcium Scoring With Traditional Assessment in Patients Presenting to the Rapid Access Chest Pain Clinic With Non-acute Chest Pain and Its Prognostic Value
- ClinicalTrials.gov ID
- NCT01660594
- Acronym / sponsor ID
- 11/LO/1693
- Conditions
- Coronary Disease
- Keywords
- coronary disease, tomography, x-ray computed, calcium, exercise test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Aug 2012 (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.
Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.
At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.
Detailed description
The study seeks to determine the usefulness of CT calcium scoring (CTCS) in patients presenting with non-acute chest pain to the rapid access chest pain clinic (RACPC) and compare it with the traditional assessment in predicting significant CAD and outcome with respect to non-fatal MI or death. The clinical, diagnostic, and follow-up data of patients in last 7 years since CTCS has been performed in the hospital would be retrospectively analysed for the purpose.
Background Patients with chest pain (excluding that of sudden onset) are routinely referred by the GPs to the RACPC centres in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. At our institution, we have also been performing CTCS in men more than 40 and women more than 50 years of age since 2003. Recent NICE guidance1 recommends that patients with low pre-test probability (10-30%) of significant coronary artery disease (CAD) have a CT calcium scoring scan and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.
This study would enable us to compare and determine the value of CTCS in patients with non-acute chest pain in predicting significant CAD and safety of absent coronary artery calcification.
Rationale for Study
- To determine if CT coronary calcium scoring adds any value to the existing clinical assessment and exercise ECG. This is not well established in patients presenting with non-acute chest pain to the rapid access chest pain clinics.
- The study would help in determining if absence of calcification on CT can be considered to have low likelihood of significant coronary artery disease and a good cardiovascular outcome over the period of follow-up. Both these issues are currently controversial in the literature in this group of patients.
STUDY OBJECTIVES
Primary Objective To determine the prognostic value of CT coronary calcium scoring in patients with non-acute chest pain for non-fatal MI and death, and compare with traditional assessment including exercise ECG.
Secondary Objectives To determine how CT coronary calcium scoring compare with traditional assessment including exercise ECG in predicting significant coronary artery disease in patients presenting with non-acute chest pain.
METHODOLOGY Design This is a retrospective cross-sectional study involving analysis of patients' clinical, diagnostic, and management data from hospital records and follow-up questionnaires for outcome. The study does not require any new diagnostic, therapeutic, or interventional procedure.
Data of patients who have presented to the chest pain clinic since October 2003 would be collected from hospital records for:
- Age, sex, type of chest pain, and risk factors. These would be used to calculate the pre-test probability of significant coronary artery disease (CAD) using Duke's score.
- Results of exercise ECG where performed.
- Results of CT calcium scoring.
- Results of other non-invasive investigations such as stress imaging and CT coronary angiography where performed.
- Results of invasive coronary angiography where performed. Patients with >70% diameter stenosis or those who underwent percutaneous stent insertion (PCI) or bypass surgery would be considered to have significant CAD.
For those patients who do not undergo any PCI or surgery as a result of above evaluation, we will try to find out if they have subsequently suffered any heart attack or died. This would again be performed through hospital records and if not available, through questionnaires send to the patients and/or their GPs as part of standard clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable chest pain | – | Other: CT calcium scoringAll patients presenting with stable chest pain and referred by their general practitioners to the chest pain clinic in the hospital who had CT calcium scoring performed besides standard assessment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who presented to our chest pain clinic between October 2003 to March 2010 with stable (non-acute) chest pain and assessed with history, physical examination, cardiovascular risk factors, chest X-ray, 12-lead resting ECG and exercise ECG.
Key inclusion criteria (3 listed)
- non-acute chest pain
- those who underwent CT calcium scoring
- availability of all relevant risk factor information
Key exclusion criteria (1 listed)
- previous coronary disease i.e., myocardial infarction or revascularization
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 calcium scoringCT Calcium scoring was performed in the patients as an imaging test in addition to the traditional assessment on the same day of patients attending the chest pain clinic on the first visit. This was performed with standard protocol and the absolute calcium score was calculated. | Other | Stable chest pain |
Primary outcome
All-cause mortality
Time frame: 7 years
1 secondary outcome
Non-fatal myocardial infarction
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
- Background: PubMed 20538674Skinner JS, Smeeth L, Kendall JM, Adams PC, Timmis A; Chest Pain Guideline Development Group. NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart. 2010 Jun;96(12):974-8. doi: 10.1136/hrt.2009.190066. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 7 years). 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 NCT01660594, which also lists 1 linked publication.
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 9 Aug 2012.