Angina PectorisCRESCENTNCT01393028
Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
A study testing Cardiac CT in people with Angina Pectoris and Chest Pain, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Chest Pain
- What is being tested?
- Cardiac CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jul 2011to Aug 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged >18 years.
- Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.
Who cannot join
- A history of surgical or percutaneous coronary revascularization
- Non-revascularized angiographic obstructive coronary artery disease (>50% diameter reduction).
- Normal invasive coronary angiography or stress imaging less than 1 years ago.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
MC Haaglanden
Leidschendam
Erasmus MC
Rotterdam
Havenziekenhuis
Rotterdam
Maasstadziekenhuis
Rotterdam
About this study
Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.
- Conditions
- Angina Pectoris, Chest Pain
- Being tested
- Cardiac CT, Standard care
- Keywords
- coronary artery disease, angina pectoris, Stable chest pain complaints
- Medical subject headings
- Angina Pectoris, Chest Pain, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTOther
Cardiac CT: calcium scan and CT coronary angiography
Standard careOther
Standard care according to international guidelines
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | Experimental | Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result Receives: Other: Cardiac CT |
| Standard care | Other | Standard diagnostic management, including stress testing and/or invasive angiography Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest pain
Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up
Measured: 1 year
Class IA Revascularizations
Number of revascularizations with an ESC class 1A indication
Measured: 1 year
Secondary outcomes (5)
Overall medical expenses
Overall medical expenses
Measured: 1 year
Cost-effectiveness
Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year.
Measured: 1 year
Radiation dose
Cumulative radiation exposure at one year
Measured: 1 year
Major adverse cardiovascular events
Composite endpoint of adverse cardiovascular events, including:
All-cause mortality Non-fatal myocardial infarction Unstable angina requiring hospital admission Late revascularization procedures (>6 months after initial evaluation)
Measured: 1 year
Quality of life
Change of quality of life at 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 posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Insufficient funds
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 Angina PectorisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Nieman, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393028
- Sponsor's protocol ID
- CRESCENT-11
- Acronym
- CRESCENT
- Status last verified
- Nov 2014
- First submitted
- 27 Jun 2011
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lubbers M, Coenen A, Bruning T, Galema T, Akkerhuis J, Krenning B, Musters P, Ouhlous M, Liem A, Niezen A, Dedic A, van Domburg R, Hunink M, Nieman K. Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease). Circ Cardiovasc Imaging. 2017 Feb;10(2):e005295. doi: 10.1161/CIRCIMAGING.116.005295.
PubMed 28174196
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01393028
- Acronym / sponsor ID
- CRESCENT / CRESCENT-11
- Conditions
- Angina Pectoris, Chest Pain
- Keywords
- coronary artery disease, angina pectoris, Stable chest pain complaints
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funds
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Jul 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.
Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | Experimental | Other: Cardiac CTCardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result |
| Standard care | Other | Other: Standard careStandard diagnostic management, including stress testing and/or invasive angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged >18 years.
- Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.
Key exclusion criteria (4 listed)
- A history of surgical or percutaneous coronary revascularization
- Non-revascularized angiographic obstructive coronary artery disease (>50% diameter reduction).
- Normal invasive coronary angiography or stress imaging less than 1 years ago.
- Inability or unwillingness to provide informed consent.
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 CTCardiac CT: calcium scan and CT coronary angiography | Other | Cardiac CT |
| Standard careStandard care according to international guidelines | Other | Standard care |
Primary outcome
Chest pain
Time frame: 1 year
Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up
Class IA Revascularizations
Time frame: 1 year
Number of revascularizations with an ESC class 1A indication
5 secondary outcomes
Overall medical expenses
Time frame: 1 year
Cost-effectiveness
Time frame: 1 year
Radiation dose
Time frame: 1 year
Major adverse cardiovascular events
Time frame: 1 year
Quality of life
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Insufficient funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Derived from this study: PubMed 28174196Lubbers M, Coenen A, Bruning T, Galema T, Akkerhuis J, Krenning B, Musters P, Ouhlous M, Liem A, Niezen A, Dedic A, van Domburg R, Hunink M, Nieman K. Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease). Circ Cardiovasc Imaging. 2017 Feb;10(2):e005295. doi: 10.1161/CIRCIMAGING.116.005295.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT in people with Angina Pectoris and Chest Pain, run by Erasmus Medical Center at 4 sites in Netherlands.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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 was stopped early (reason given: Insufficient funds). 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?
Chest pain (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01393028, 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 13 Nov 2014.