Myocardium; InjuryAMI-NCSNCT01960309
Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
A study testing Minimal invasive cardiac imaging in people with Myocardium; Injury and Coronary Artery Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myocardium; Injury, Coronary Artery Disease
- What is being tested?
- Minimal invasive cardiac imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Aug 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days
- Age > 59 years
- Troponin_I elevation > 0.06 ng/ml in the first 3 post-operative days
- No clinical symptoms of myocardial ischemia
Who cannot join
- Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis
- Perioperative ST-elevation myocardial infarction (STEMI)
- Perioperative symptomatic angina with troponin elevation
- Patients with a history or ECG-signs of myocardial infarction
- Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy
- Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography.
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- Contra-indication for CMR such as claustrophobia or metal prosthesis
- Allergic reaction to CT-contrast or gadolinium
- Renal dysfunction with GFR < 50 ml/min, as determined after the operation
- Unstable hemodynamics or other conditions disabling transport to the Radiology department
- Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR
- Admission at the ICU
- Poor prognosis due to other medical conditions e.g. malignancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, Utrecht
Hendrik M. Nathoe, MD PhD, + 31 88 755 7273, h.m.nathoe@umcutrecht.nl
Hendrik M. Nathoe, MD PhD
About this study
This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.
- Conditions
- Myocardium; Injury, Coronary Artery Disease
- Being tested
- Minimal invasive cardiac imaging
- Medical subject headings
- Wounds and Injuries, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive cardiac imagingOther
- Coronary CT angiography (CCTA)
- Coronary magnetic resonance imaging (CMR)
- Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| 1. TnI elevation | Experimental | TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
| 2. TnI elevation | Experimental | TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
| 3. TnI elevation | Experimental | TnI>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
| 4. TnI elevation | Experimental | TnI >6.00 ng/ml, ischemia on ECG and Hb<5.1. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
| 5. TnI elevation | Experimental | TnI >6.00 ng/ml, ischemia on ECG and Hb>5.0. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
| Control | Active comparator | TnI <0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging Receives: Other: Minimal invasive cardiac imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease
Coronary artery disease with luminal narrowing > 50 % in one or more major epicardial vessels by CCTA.
Measured: During hospital admission
Secondary outcomes (3)
Coronary calcium score
Agatston coronary calcium score
Measured: During hospital admission
Extent of coronary artery atherosclerosis
Presence and extent of coronary artery atherosclerosis as measured with coronary CCTA
Measured: During hospital admission
Minimal myocardial injury
Minimal myocardial injury measured by late gadolinium enhancement on CMR.
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardium; InjuryStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilton A van Klei, UMC Utrecht
- Investigators
- Hendrik M. Nathoe, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960309
- Sponsor's protocol ID
- AMI-NCS
- Acronym
- AMI-NCS
- Status last verified
- Dec 2014
- First submitted
- 30 Jul 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
- ClinicalTrials.gov ID
- NCT01960309
- Acronym / sponsor ID
- AMI-NCS / AMI-NCS
- Conditions
- Myocardium; Injury, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 10 Oct 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.
This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1. TnI elevation | Experimental | Other: Minimal invasive cardiac imagingTnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging |
| 2. TnI elevation | Experimental | Other: Minimal invasive cardiac imagingTnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging |
| 3. TnI elevation | Experimental | Other: Minimal invasive cardiac imagingTnI>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging |
| 4. TnI elevation | Experimental | Other: Minimal invasive cardiac imagingTnI >6.00 ng/ml, ischemia on ECG and Hb<5.1. Intervention: minimal invasive cardiac imaging |
| 5. TnI elevation | Experimental | Other: Minimal invasive cardiac imagingTnI >6.00 ng/ml, ischemia on ECG and Hb>5.0. Intervention: minimal invasive cardiac imaging |
| Control | Active comparator | Other: Minimal invasive cardiac imagingTnI <0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days
- Age > 59 years
- Troponin_I elevation > 0.06 ng/ml in the first 3 post-operative days
- No clinical symptoms of myocardial ischemia
Key exclusion criteria (13 listed)
- Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis
- Perioperative ST-elevation myocardial infarction (STEMI)
- Perioperative symptomatic angina with troponin elevation
- Patients with a history or ECG-signs of myocardial infarction
- Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy
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 |
|---|---|---|
| Minimal invasive cardiac imaging* Coronary CT angiography (CCTA) * Coronary magnetic resonance imaging (CMR) * Echocardiography | Other | 1. TnI elevation, 2. TnI elevation, 3. TnI elevation, 4. TnI elevation, 5. TnI elevation, Control |
Primary outcome
Coronary artery disease
Time frame: During hospital admission
Coronary artery disease with luminal narrowing > 50 % in one or more major epicardial vessels by CCTA.
3 secondary outcomes
Coronary calcium score
Time frame: During hospital admission
Extent of coronary artery atherosclerosis
Time frame: During hospital admission
Minimal myocardial injury
Time frame: During hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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.
Hendrik M. Nathoe, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive cardiac imaging in people with Myocardium; Injury and Coronary Artery Disease, run by UMC Utrecht 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hendrik M. Nathoe, MD PhD (+31 88 755 7273, H.M.Nathoe@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery disease (time frame: During hospital admission). 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 3 Dec 2014.