Stable Angina PectorisPhase 3CRESCENT2NCT02291484
Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
A Phase 3 study testing Cardiac CT scan in people with Stable Angina Pectoris and Coronary Artery Disease, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina Pectoris, Coronary Artery Disease
- What is being tested?
- Cardiac CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesNetherlands
- Study dates
- Aug 2013to May 2016
- Phase
- Phase 3
- 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.
- Chest pain symptoms suspicious of coronary heart disease.
- Pre-test probability of coronary artery disease >10%
Who cannot join
- History of CAD: prior myocardial infarction or revascularization procedure
- Contra-indication to radiation exposure (CT/SPECT): pregnancy
- Contra-indication to iodine contrast media: renal failure, iodine allergy
- Contra-indications to adenosine
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Albert Schweizerzieknhuis
Dordrecht, 3318 AT
Maastricht University Medical Center
Maastricht, 6229 HX
Erasmus MC
Rotterdam, 3015CE
Maasstadziekenhuis
Rotterdam
About this study
Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.
Read the detailed description
Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.
Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.
Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.
Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.
Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD.
Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management.
Main study parameters/endpoints:
Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.
- Conditions
- Stable Angina Pectoris, Coronary Artery Disease
- Being tested
- Cardiac CT scan
- Keywords
- Computed tomography, Coronary angiography, Coronary artery disease, Perfusion imaging, Comparative effectiveness, Randomized controlled trial, Cost-effectiveness
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT scanDevice
CT-guided management
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive cardiac CT | Experimental | Tiered cardiac CT protocol:
1. CT calcium scan
2. CT angiography (if calcium scan positive or high pre-test probability)
3. CT perfusion (if >50% stenosis on CTA, or cannot be ruled out) Receives: Device: Cardiac CT scan |
| Standard care | No intervention | Standard diagnostic management of suspected CAD, using stress testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of negative invasive angiograms (as percentage of total population)
Number of performed invasive angiograms with no CAD requiring intervention
Measured: 6 months
Secondary outcomes (6)
Chest pain complaints
Proportion of patients experiencing symptoms of chest pain
Measured: 6 months
Quality of life
Questionnaire based quality of life score
Measured: 6 months
Major adverse event rate
Death, myocardial infarction, unstable angina, urgent revascularizations, CVA
Measured: 6 months
Radiation exposure
Cumulative radiation dose from diagnostic and therapeutic interventions
Measured: 6 months
Number of diagnostic and therapeutic procedures
Number of diagnostic and therapeutic procedures
Measured: 6 months
Medical expenses
All medical expenses related to the diagnosis and treatment of suspected CAD
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionMay 2016
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 Stable 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 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
- Investigators
- Koen Nieman, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291484
- Sponsor's protocol ID
- MEC2013022
- Acronym
- CRESCENT2
- Status last verified
- Aug 2016
- First submitted
- 11 Nov 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.
PubMed 29248657
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
- ClinicalTrials.gov ID
- NCT02291484
- Acronym / sponsor ID
- CRESCENT2 / MEC2013022
- Conditions
- Stable Angina Pectoris, Coronary Artery Disease
- Keywords
- Computed tomography, Coronary angiography, Coronary artery disease, Perfusion imaging, Comparative effectiveness, Randomized controlled trial, Cost-effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Nov 2014 (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.
Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.
Detailed description
Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.
Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.
Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.
Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.
Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD.
Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management.
Main study parameters/endpoints:
Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive cardiac CT | Experimental | Device: Cardiac CT scanTiered cardiac CT protocol: 1. CT calcium scan 2. CT angiography (if calcium scan positive or high pre-test probability) 3. CT perfusion (if >50% stenosis on CTA, or cannot be ruled out) |
| Standard care | No intervention | –Standard diagnostic management of suspected CAD, using stress testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged >18 years.
- Chest pain symptoms suspicious of coronary heart disease.
- Pre-test probability of coronary artery disease >10%
Key exclusion criteria (5 listed)
- History of CAD: prior myocardial infarction or revascularization procedure
- Contra-indication to radiation exposure (CT/SPECT): pregnancy
- Contra-indication to iodine contrast media: renal failure, iodine allergy
- Contra-indications to adenosine
- 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 CT scanCT-guided management | Device | Comprehensive cardiac CT |
Primary outcome
Rate of negative invasive angiograms (as percentage of total population)
Time frame: 6 months
Number of performed invasive angiograms with no CAD requiring intervention
6 secondary outcomes
Chest pain complaints
Time frame: 6 months
Quality of life
Time frame: 6 months
Major adverse event rate
Time frame: 6 months
Radiation exposure
Time frame: 6 months
Number of diagnostic and therapeutic procedures
Time frame: 6 months
Medical expenses
Time frame: 6 months
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 4 Aug 2016.
- Derived from this study: PubMed 29248657Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.
- Individual participant dataSharing planned: No
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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.
Koen Nieman, MD, PhD principal investigator
Erasmus Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiac CT scan in people with Stable Angina Pectoris and Coronary Artery Disease, 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 3 inclusion and 5 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 4 Aug 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of negative invasive angiograms (as percentage of total population) (time frame: 6 months). 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 NCT02291484, 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 4 Aug 2016.