Ischemic Heart DiseaseCATCHNCT01534000
Cardiac-CT in the Treatment of Acute Chest Pain
A study testing Cardiac computed tomographic angiography (CCTA) in people with Ischemic Heart Disease, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Cardiac computed tomographic angiography (CCTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jan 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
- Admittance because of Chest pain
- Non- or non-diagnostic ecg-changes.
- Normal biomarkers for ischemia (Troponins)
- Chest X-ray without pathological findings associated with chest pain.
Who cannot join
- Women of childbearing age, or > 40 years and using approved contraception.
- Claustrophobia
- Patients with geographical residence, that complicates follow-up
- Patients with mental or physical conditions that impede follow-up
- Increase in Troponins
- New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion> 4 mm in> 2 anatomically connected derivations.
Show all 9Show fewer
- Allergy to iodinated contrast agents
- Serum creatinine greater than 130 mg/l
- Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.
Methods:
Read more
Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).
After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.
- Conditions
- Ischemic Heart Disease
- Being tested
- Cardiac computed tomographic angiography (CCTA)
- Keywords
- Cardiac CT, Ischemic heat disease, Stress test
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac computed tomographic angiography (CCTA)Procedure or surgery
Also called Adenosin for CT myocardial perfusion
Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.
| Study group | Role | What they receive |
|---|---|---|
| CT guided group | Active comparator | For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA) Receives: Procedure: Cardiac computed tomographic angiography (CCTA) |
| Control group | No intervention | Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography). A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
Measured: 1 year follow-up
Secondary outcomes (10)
Cardiac death
Measured: 1 year follow-up
myocardial infarction
Measured: 1 year follow-up
readmissions for chest pain
Measured: 1 year follow-up
Revascularisation
Measured: 1 year follow-up
unstabile angina
Measured: 1-year follow-up
continued chest pain
Measured: 1 year follow-up
Quality of life (SF-36)
Measured: 1-year follow-up
medication
Measured: 1-year follow-up
non-cardiac findings on CT
Measured: 1-year follow-up
downstream testing
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
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 Ischemic Heart 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens D Hove, MD,PHD, Hvidovre University Hospital
- Investigators
- Jesper J Linde, MD, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534000
- Sponsor's protocol ID
- H-C-2009-053
- Acronym
- CATCH
- Status last verified
- Jun 2014
- First submitted
- 22 Dec 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.
PubMed 26577263
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac-CT in the Treatment of Acute Chest Pain
- ClinicalTrials.gov ID
- NCT01534000
- Acronym / sponsor ID
- CATCH / H-C-2009-053
- Conditions
- Ischemic Heart Disease
- Keywords
- Cardiac CT, Ischemic heat disease, Stress test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Feb 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.
Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.
Methods:
Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).
After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT guided group | Active comparator | Procedure: Cardiac computed tomographic angiography (CCTA)For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA) |
| Control group | No intervention | –Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography). A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admittance because of Chest pain
- Non- or non-diagnostic ecg-changes.
- Normal biomarkers for ischemia (Troponins)
- Chest X-ray without pathological findings associated with chest pain.
Key exclusion criteria (9 listed)
- Women of childbearing age, or > 40 years and using approved contraception.
- Claustrophobia
- Patients with geographical residence, that complicates follow-up
- Patients with mental or physical conditions that impede follow-up
- Increase in Troponins
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 computed tomographic angiography (CCTA)Also: Adenosin for CT myocardial perfusionPatients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose. | Procedure or surgery | CT guided group |
Primary outcome
combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
Time frame: 1 year follow-up
10 secondary outcomes
Cardiac death
Time frame: 1 year follow-up
myocardial infarction
Time frame: 1 year follow-up
readmissions for chest pain
Time frame: 1 year follow-up
Revascularisation
Time frame: 1 year follow-up
unstabile angina
Time frame: 1-year follow-up
continued chest pain
Time frame: 1 year follow-up
Quality of life (SF-36)
Time frame: 1-year follow-up
medication
Time frame: 1-year follow-up
non-cardiac findings on CT
Time frame: 1-year follow-up
downstream testing
Time frame: 1-year follow-up
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 19 Jun 2014.
- Derived from this study: PubMed 26577263Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
Jesper J Linde, MD study director
Hvidovre University Hospital
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 computed tomographic angiography (CCTA) in people with Ischemic Heart Disease, run by Hvidovre University Hospital at 1 site 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 4 inclusion and 9 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 19 Jun 2014. 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 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?
combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain (time frame: 1 year follow-up). 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 NCT01534000, 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 19 Jun 2014.