Coronary Artery DiseaseCATCH2NCT02014311
CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion
A study testing CTA+CTP guided treatment strategy and CTA guided treatment strategy in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 7 sites in Denmark.
Trial summary
The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CTA+CTP guided treatment strategy and CTA guided treatment strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 7 sitesDenmark
- Study dates
- Oct 2013to Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent acute-onset chest pain where coronary artery disease is suspected
- During initial acute hospitalization:
- Normal coronary biomarkers (Troponins)
- No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
- Age ≥50 years
- ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%
Who cannot join
- Known Iodine contrast allergy
- Estimated GFR below 50 ml/min
- Adenosine intolerance - known allergic asthma
- Previous CABG
- Patient related circumstances which preclude informed consent from the patient
- Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
- Expected survival of less that 2 years
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
Department of Cardiology, Amager University Hospital
Copenhagen
Department of Cardiology, Bispebjerg University Hospital
Copenhagen
Department of Cardiology, Gentofte University Hospital
Copenhagen
Department of Cardiology, Glostrup University Hospital
Copenhagen
Department of Cardiology, Herlev Hospital
Copenhagen
Department of Cardiology, Hvidovre University Hospital
Copenhagen
About this study
Official title: Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial
The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.
The following main hypothesis will be tested:
- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy
Read the detailed description
MATERIAL
- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.
METHODS
-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.
- Conditions
- Coronary Artery Disease
- Being tested
- CTA+CTP guided treatment strategy, CTA guided treatment strategy
- Keywords
- Multidetector Computed Tomography, Myocardial Perfusion Imaging, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA+CTP guided treatment strategyProcedure or surgery
CTA+CTP guided treatment strategy
CTA guided treatment strategyProcedure or surgery
CTA guided treatment strategy
| Study group | Role | What they receive |
|---|---|---|
| CTA+CTP guided treatment strategy | Experimental | Patients with adenosine stress induced regional myocardial hypoperfusion (CT perfusion imaging) in combination with a corresponding epicardial coronary vessel with >50% stenosis (Coronary CT angiography) will be referred for invasive investigation within 30 days after study inclusion - CTP-INTERVENTION Receives: Procedure: CTA+CTP guided treatment strategy |
| CTA guided treatment strategy | Active comparator | Patients with at least one epicardial coronary artery stenosis >50% (Coronary CT angiography) will be referred for invasive investigation within 30 days after initial discharge from the hospital - CONTROL Receives: Procedure: CTA guided treatment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of coronary revascularization among included patients referred for invasive investigation
Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded
Measured: Within 60 days of study inclusion
Secondary outcomes (4)
Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death
Measured: Within 3, 12 and 24 months after CT examination
New referral for invasive investigation following inititial evaluation
Measured: 3, 12 and 24 months after CT examination
Coronary revascularization - not including revascularization related to index evaluation
Measured: 3, 12 and 24 months after CT examination
Invasive procedure related events
Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded
Measured: Within 30 days of invasive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2017
- Study completionDec 2022
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Amager Hospital, Bispebjerg Hospital, Herlev Hospital, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Klaus F Kofoed, MD, DmSc, Principal investigator, Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014311
- Sponsor's protocol ID
- H-3-2013-065
- Acronym
- CATCH2
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2013
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Linde JJ, Kofoed KF, Sorgaard M, Kelbaek H, Jensen GB, Nielsen WB, Hove JD. Cardiac computed tomography guided treatment strategy in patients with recent acute-onset chest pain: results from the randomised, controlled trial: CArdiac cT in the treatment of acute CHest pain (CATCH). Int J Cardiol. 2013 Oct 15;168(6):5257-62. doi: 10.1016/j.ijcard.2013.08.020. Epub 2013 Aug 14.
PubMed 23998546Kuhl JT, Linde JJ, Fuchs A, Kristensen TS, Kelbaek H, George RT, Hove JD, Kofoed KF. Patterns of myocardial perfusion in humans evaluated with contrast-enhanced 320 multidetector computed tomography. Int J Cardiovasc Imaging. 2012 Oct;28(7):1739-47. doi: 10.1007/s10554-011-9986-z. Epub 2011 Dec 6.
PubMed 22143171
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02014311
- Acronym / sponsor ID
- CATCH2 / H-3-2013-065
- Conditions
- Coronary Artery Disease
- Keywords
- Multidetector Computed Tomography, Myocardial Perfusion Imaging, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Amager Hospital, Bispebjerg Hospital, Herlev Hospital, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 18 Dec 2013 (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.
The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.
The following main hypothesis will be tested:
- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy
Detailed description
MATERIAL
- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.
METHODS
-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA+CTP guided treatment strategy | Experimental | Procedure: CTA+CTP guided treatment strategyPatients with adenosine stress induced regional myocardial hypoperfusion (CT perfusion imaging) in combination with a corresponding epicardial coronary vessel with >50% stenosis (Coronary CT angiography) will be referred for invasive investigation within 30 days after study inclusion - CTP-INTERVENTION |
| CTA guided treatment strategy | Active comparator | Procedure: CTA guided treatment strategyPatients with at least one epicardial coronary artery stenosis >50% (Coronary CT angiography) will be referred for invasive investigation within 30 days after initial discharge from the hospital - CONTROL |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recent acute-onset chest pain where coronary artery disease is suspected
- During initial acute hospitalization:
- Age ≥50 years
- ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%
Key exclusion criteria (7 listed)
- Known Iodine contrast allergy
- Estimated GFR below 50 ml/min
- Adenosine intolerance - known allergic asthma
- Previous CABG
- Patient related circumstances which preclude informed consent from the patient
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 |
|---|---|---|
| CTA+CTP guided treatment strategyCTA+CTP guided treatment strategy | Procedure or surgery | CTA+CTP guided treatment strategy |
| CTA guided treatment strategyCTA guided treatment strategy | Procedure or surgery | CTA guided treatment strategy |
Primary outcome
Frequency of coronary revascularization among included patients referred for invasive investigation
Time frame: Within 60 days of study inclusion
Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded
4 secondary outcomes
Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death
Time frame: Within 3, 12 and 24 months after CT examination
New referral for invasive investigation following inititial evaluation
Time frame: 3, 12 and 24 months after CT examination
Coronary revascularization - not including revascularization related to index evaluation
Time frame: 3, 12 and 24 months after CT examination
Invasive procedure related events
Time frame: Within 30 days of invasive procedure
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 12 Dec 2022.
- Background: PubMed 23998546Linde JJ, Kofoed KF, Sorgaard M, Kelbaek H, Jensen GB, Nielsen WB, Hove JD. Cardiac computed tomography guided treatment strategy in patients with recent acute-onset chest pain: results from the randomised, controlled trial: CArdiac cT in the treatment of acute CHest pain (CATCH). Int J Cardiol. 2013 Oct 15;168(6):5257-62. doi: 10.1016/j.ijcard.2013.08.020. Epub 2013 Aug 14.
- Background: PubMed 22143171Kuhl JT, Linde JJ, Fuchs A, Kristensen TS, Kelbaek H, George RT, Hove JD, Kofoed KF. Patterns of myocardial perfusion in humans evaluated with contrast-enhanced 320 multidetector computed tomography. Int J Cardiovasc Imaging. 2012 Oct;28(7):1739-47. doi: 10.1007/s10554-011-9986-z. Epub 2011 Dec 6.
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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.
Klaus F Kofoed, MD, DmSc principal investigator
Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTA+CTP guided treatment strategy and CTA guided treatment strategy in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 7 sites in Denmark.
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 6 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: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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?
Frequency of coronary revascularization among included patients referred for invasive investigation (time frame: Within 60 days of study inclusion). 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 NCT02014311, 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 12 Dec 2022.