Non ST Elevation Myocardial InfarctionNCT01833338
Non-invasive and Invasive Plaque Characterisation
A study testing Imaging in people with Non ST Elevation Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Elevation Myocardial Infarction
- What is being tested?
- Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2011to May 2013
- 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
- Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads); - Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.
Who cannot join
- Persistent ST-elevation of >1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) < 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen, Departments of Cardiology and Radiology
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Coronary Artery Plaque Characterisation With Non-invasive Multi-Slice Computed Tomography and Invasive Intravascular Ultrasound and Optical Coherence Tomography in Patients With Acute Coronary Syndromes Without ST-segment Elevation
The accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.
- Conditions
- Non ST Elevation Myocardial Infarction
- Being tested
- Imaging
- Keywords
- Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDevice
Also called OCT: C7-XR™ OCT Intravascular Imaging System, St.Jude Medical, IVUS: Galaxy 2 IVUS Imaging System, Boston Scientific, MSCT: Dual-source CT scanner Somatom Definition, Siemens Healhtcare
All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | There is only one arm in this study. All patients undergo MSCT, IVUS and OCT. Receives: Device: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.
All imaging methods will be performed in each patient. A 24 hour period is the maximum allowed time gap between MSCT and invasive imaging (OCT/IVUS).
Measured: 24 hours
Secondary outcomes (1)
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.
A maximum interval of 24 hours between MSCT and IVUS/OCT is allowed in this study.
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 posted16 Apr 2013 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The study was terminated based on an included stopping rule in the study protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Elevation Myocardial InfarctionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabija Pundziute, University Medical Center Groningen
- Investigators
- Gabija Pundziute, MD, PhD, Principal investigator, Department of CardiologyTineke Willems, MD, PhD, Principal investigator, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833338
- Sponsor's protocol ID
- METcUMCG 2010.266
- Status last verified
- Sep 2014
- First submitted
- 4 Mar 2013
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Plaque Characterisation With Non-invasive Multi-Slice Computed Tomography and Invasive Intravascular Ultrasound and Optical Coherence Tomography in Patients With Acute Coronary Syndromes Without ST-segment Elevation
- ClinicalTrials.gov ID
- NCT01833338
- Acronym / sponsor ID
- METcUMCG 2010.266
- Conditions
- Non ST Elevation Myocardial Infarction
- Keywords
- Non ST elevation myocardial infarction, optical coherence tomography, intravascular ultrasound, multi-slice computed tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on an included stopping rule in the study protocol
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Apr 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 accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: ImagingThere is only one arm in this study. All patients undergo MSCT, IVUS and OCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads); - Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.
Key exclusion criteria (1 listed)
- Persistent ST-elevation of >1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) < 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability 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 |
|---|---|---|
| ImagingAlso: OCT: C7-XR™ OCT Intravascular Imaging System, St.Jude Medical, IVUS: Galaxy 2 IVUS Imaging System, Boston Scientific, MSCT: Dual-source CT scanner Somatom Definition, Siemens HealhtcareAll patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging | Device | Single arm |
Primary outcome
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.
Time frame: 24 hours
All imaging methods will be performed in each patient. A 24 hour period is the maximum allowed time gap between MSCT and invasive imaging (OCT/IVUS).
1 secondary outcome
Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: The study was terminated based on an included stopping rule in the study protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
Gabija Pundziute, MD, PhD principal investigator
Department of Cardiology
Tineke Willems, MD, PhD principal investigator
Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging in people with Non ST Elevation Myocardial Infarction, run by University Medical Center Groningen at 1 site 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 1 inclusion and 1 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 11 Sep 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 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: The study was terminated based on an included stopping rule in the study protocol). 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?
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated. (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 11 Sep 2014.