Coronary Artery DiseaseNCT01476579
Comparison of Low-radiation Dose CT Angiography With Invasive Coronary Angiography in Stable Coronary Disease
A study testing Cardiac Computer Tomography in people with Coronary Artery Disease, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
This study is evaluating the performance of modern CT coronar angiography with low radiation technique compared to conventional invasive coronar angiography. The patients recruited will already be accepted for invasive coronary angiography based on clinical presentation, ECG and biochemical parameters. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac Computer Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 769 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Jan 2022
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 800 Patients who are scheduled to undergo conventional invasive coronary angiogram will be recruited at the University hospital of North Norway, Tromsø.
Who cannot join
- Acute coronary syndrome with positive high sensitive troponin.
- Renal failure with glomerular filtration rate (GFR) < 30
- Contraindication to contrast medium
- Symptomatic Tachycardia >110 or bradycardia < 40
- Pregnancy
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of New Generation Low-dose CT Coronary Angiography
This study is evaluating the performance of modern CT coronar angiography with low radiation technique compared to conventional invasive coronar angiography. The patients recruited will already be accepted for invasive coronary angiography based on clinical presentation, ECG and biochemical parameters. An "all-comers" design to avoid selection bias and no additional B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to rule out significant coronary artery disease with sensitivity > 95 % and negative predictive value > 95 % with very low radiation doses.
Read the detailed description
Conventional invasive coronary angiography (CICA) is associated with few but serious complications. It is time consuming for the patient and incur costs to the health institution due to the post-procedure observation needed. Coronary computer tomography angiography (CCTA) is a good alternative to CICA to rule out coronary artery disease (CAD). Moderate to excellent sensitivity and negative predictive values have been reported with 64-slice CT angiography. The main ethical problem has been the radiation doses given to the patient during CT angiography which was high >10 millisievert(mSv). With 265 or higher slice CT machines and radiation dose reduction techniques, it is possible to evaluate coronary anatomy with radiation doses below 1 mSv. Heart rate reduction with B-blockers is in most cases not necessary with new generation CT machines but is recommended in guidelines.
800 patients already accepted for CICA based on clinical information will be scheduled to undergo CCTA prior to invasive coronary angiography. Coronary anatomy will be described according to American Heart Association (AHA) classification with 17 segment analysis. The main purpose of the study is to achieve high sensitivity and high negative predictive value with CT angiography. Radiation doses in relation to gender and body mass index (BMI) will be monitored. In addition we will measure coronary calcification (Agatson score) and look at any association to the Vitamin D and calcium metabolism. Patient reported quality of life evaluation with validated questionnaires and long term follow up (5 and 10 years) regarding clinical endpoints.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac Computer Tomography
- Keywords
- Coronary CT, Sensitivity, Specificity, Radiation, Tomography, X-Ray Computed, Coronary angiography
- Medical subject headings
- Coronary Artery Disease, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Computer TomographyDevice
Compare Cardiac CT with reference standard wich is conventional invasive coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive CT coronary angiography | Other | This study is evaluating diagnostic accuracy of non-invasive CT coronary angiography with invasive coronary angiography. Receives: Device: Cardiac Computer Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
The results from the CT coronary angiography will be compared with the results from the conventional invasive coronary angiography which in this respect is considered the "gold standard". The sensitivity and specificity for the CT angiography regarding detection of significant coronary stenosis (ie more than 50 % lumen narrowing with the angiographic result as reference) and for revascularisation will be calculated separately.
Measured: 24 hours
Secondary outcomes (4)
Change in quality of life and symptom score
Change from baseline in quality of life and symptoms as measured with SF-12, HADS og SEATTLE will be assessed both for patients with and without significant coronary pathology with postal questionnaires at 6 months, 1 and 3 years after the CT angiography
Measured: 6 months, 1 and 3 years
Coronary calcium score impact on pretest coronary risk scoring and prognosis
The change in pretest probability for detection of significant stenosis and revascularisation by calcium score will be calculated in addition to prediction of 5 and 10 year fatal and non fatal cardiovascular events.
Measured: 24 hours, 5 and 10 years
Vitamin D and other novel cardiovascular risk factors
The association of vitamin D levels (25OHD) and Single Nucleotide Polymorphism (SNP) related to vitamin D and calcium metabolism to presence of coronary plaques and their calcium content will be analysed as well as risk of fatal and non fatal coronary events. When events are registered other new novel risk markers detected in the Tromso Study will be measured in a nested case control design.
Measured: 24 hours, 5 and 10 years
Real life radiation risk with new CT scanners and conventional invasive angiography
The radiation doses will be measured independent of supplier software for both procedures and compared. Impact of risk factors on radiation dosage and image quality will be determined.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- AMJID IQBAL, MD, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476579
- Sponsor's protocol ID
- 2011/123
- Status last verified
- Apr 2019
- First submitted
- 9 Nov 2011
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of New Generation Low-dose CT Coronary Angiography
- ClinicalTrials.gov ID
- NCT01476579
- Acronym / sponsor ID
- 2011/123
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary CT, Sensitivity, Specificity, Radiation, Tomography, X-Ray Computed, Coronary angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 769 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 22 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.
This study is evaluating the performance of modern CT coronar angiography with low radiation technique compared to conventional invasive coronar angiography. The patients recruited will already be accepted for invasive coronary angiography based on clinical presentation, ECG and biochemical parameters. An "all-comers" design to avoid selection bias and no additional B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to rule out significant coronary artery disease with sensitivity > 95 % and negative predictive value > 95 % with very low radiation doses.
Detailed description
Conventional invasive coronary angiography (CICA) is associated with few but serious complications. It is time consuming for the patient and incur costs to the health institution due to the post-procedure observation needed. Coronary computer tomography angiography (CCTA) is a good alternative to CICA to rule out coronary artery disease (CAD). Moderate to excellent sensitivity and negative predictive values have been reported with 64-slice CT angiography. The main ethical problem has been the radiation doses given to the patient during CT angiography which was high >10 millisievert(mSv). With 265 or higher slice CT machines and radiation dose reduction techniques, it is possible to evaluate coronary anatomy with radiation doses below 1 mSv. Heart rate reduction with B-blockers is in most cases not necessary with new generation CT machines but is recommended in guidelines.
800 patients already accepted for CICA based on clinical information will be scheduled to undergo CCTA prior to invasive coronary angiography. Coronary anatomy will be described according to American Heart Association (AHA) classification with 17 segment analysis. The main purpose of the study is to achieve high sensitivity and high negative predictive value with CT angiography. Radiation doses in relation to gender and body mass index (BMI) will be monitored. In addition we will measure coronary calcification (Agatson score) and look at any association to the Vitamin D and calcium metabolism. Patient reported quality of life evaluation with validated questionnaires and long term follow up (5 and 10 years) regarding clinical endpoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive CT coronary angiography | Other | Device: Cardiac Computer TomographyThis study is evaluating diagnostic accuracy of non-invasive CT coronary angiography with invasive coronary angiography. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. 800 Patients who are scheduled to undergo conventional invasive coronary angiogram will be recruited at the University hospital of North Norway, Tromsø.
Key exclusion criteria (6 listed)
- Acute coronary syndrome with positive high sensitive troponin.
- Renal failure with glomerular filtration rate (GFR) < 30
- Contraindication to contrast medium
- Symptomatic Tachycardia >110 or bradycardia < 40
- Pregnancy
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 |
|---|---|---|
| Cardiac Computer TomographyCompare Cardiac CT with reference standard wich is conventional invasive coronary angiography. | Device | Non-invasive CT coronary angiography |
Primary outcome
Sensitivity and specificity
Time frame: 24 hours
The results from the CT coronary angiography will be compared with the results from the conventional invasive coronary angiography which in this respect is considered the "gold standard". The sensitivity and specificity for the CT angiography regarding detection of significant coronary stenosis (ie more than 50 % lumen narrowing with the angiographic result as reference) and for revascularisation will be calculated separately.
4 secondary outcomes
Change in quality of life and symptom score
Time frame: 6 months, 1 and 3 years
Coronary calcium score impact on pretest coronary risk scoring and prognosis
Time frame: 24 hours, 5 and 10 years
Vitamin D and other novel cardiovascular risk factors
Time frame: 24 hours, 5 and 10 years
Real life radiation risk with new CT scanners and conventional invasive angiography
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
AMJID IQBAL, MD, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Computer Tomography in people with Coronary Artery Disease, run by University Hospital of North Norway at 1 site in Norway.
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 6 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 18 Apr 2019. 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 Norway. 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?
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?
Sensitivity and specificity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.