Non-ST-Elevation Myocardial InfarctionNCT01122069
Contrast Echocardiography in Non-ST Elevation Myocardial Infarction
An observational study of Non-ST-Elevation Myocardial Infarction, run by University of Bergen at 1 site in Norway.
Trial summary
In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are… 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?
- Perflutren Lipid Microsphere ultrasound contrast
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2008to Jul 2009
- Phase
- Observational
- 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
Study population: 110 patients with acute non-ST elevation myocardial infarction
Who may be able to join
- acute non-ST elevation myocardial infarction
Who cannot join
- hemodynamic unstable
- mechanical prosthetic heart valve
- severly reduced pulmonary function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction
In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours.
Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease.
The purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.
- Conditions
- Non-ST-Elevation Myocardial Infarction
- Being tested
- Perflutren Lipid Microsphere ultrasound contrast
- 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.
Perflutren Lipid Microsphere ultrasound contrastOther
Also called Luminity
Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| Contrast echocardiography | 110 patients with acute non-ST elevation myocardial infarct were examined with contrast echocardiography prior to coronary angiography. Receives: Other: Perflutren Lipid Microsphere ultrasound contrast |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionJul 2009
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Eva Gerdts, University of Bergen
- Investigators
- Mai Tone Lønnebakken, MD, Principal investigator, University of Bergen, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122069
- Sponsor's protocol ID
- MCE-NSTEMI
- Other IDs
- REK237.07
- Status last verified
- Jun 2025
- First submitted
- 10 May 2010
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Eskerud I, Gerdts E, Nordrehaug JE, Lonnebakken MT. Global Coronary Artery Plaque Area is Associated with Myocardial Hypoperfusion in Women with Non-ST Elevation Myocardial Infarction. J Womens Health (Larchmt). 2015 May;24(5):367-73. doi: 10.1089/jwh.2014.4920. Epub 2015 Feb 18.
PubMed 25692527Lonnebakken MT, Nordrehaug JE, Gerdts E. No gender difference in the extent of myocardial ischemia in non-ST elevation myocardial infarction. Eur J Prev Cardiol. 2014 Jan;21(1):123-9. doi: 10.1177/2047487312454107. Epub 2012 Jul 2.
PubMed 22752464
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Echocardiography in Assessment of Myocardial Perfusion in Patients With Non-ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01122069
- Acronym / sponsor ID
- MCE-NSTEMI
- Conditions
- Non-ST-Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 May 2010 (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.
In patients with acute myocardial infarction, treatment logistics are primarily defined based upon ST segment shift in the electrocardiogram. While patients with ST elevation (STEMI) are forwarded to immediate coronary angiography and percutaneous coronary intervention, patients without ST elevation (NSTEMI) are initially medically treated and recommended coronary angiography within 48-72 hours.
Early invasive treatment has been found cost-effective in intermediate and high-risk NSTEMI patients and current guidelines recommend use of the Thrombolysis in Myocardial Infarction (TIMI) risk score to identify patients who will benefit from early intervention due to high risk of new infraction and cardiovascular death. However, new research has suggested that TIMI risk score may not always identify patients with severe angiographic disease.
The purpose of this study was to assess if contrast echocardiography could be used to identify NSTEMI patients with angiographically severe disease independent of their TIMI risk score.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast echocardiography | – | Other: Perflutren Lipid Microsphere ultrasound contrast110 patients with acute non-ST elevation myocardial infarct were examined with contrast echocardiography prior to coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 110 patients with acute non-ST elevation myocardial infarction
Key inclusion criteria (1 listed)
- acute non-ST elevation myocardial infarction
Key exclusion criteria (3 listed)
- hemodynamic unstable
- mechanical prosthetic heart valve
- severly reduced pulmonary function
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 |
|---|---|---|
| Perflutren Lipid Microsphere ultrasound contrastAlso: LuminityPerflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus | Other | Contrast echocardiography |
Primary outcome
Not reported in the source record.
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 15 Jun 2025.
- Derived from this study: PubMed 25692527Eskerud I, Gerdts E, Nordrehaug JE, Lonnebakken MT. Global Coronary Artery Plaque Area is Associated with Myocardial Hypoperfusion in Women with Non-ST Elevation Myocardial Infarction. J Womens Health (Larchmt). 2015 May;24(5):367-73. doi: 10.1089/jwh.2014.4920. Epub 2015 Feb 18.
- Derived from this study: PubMed 22752464Lonnebakken MT, Nordrehaug JE, Gerdts E. No gender difference in the extent of myocardial ischemia in non-ST elevation myocardial infarction. Eur J Prev Cardiol. 2014 Jan;21(1):123-9. doi: 10.1177/2047487312454107. Epub 2012 Jul 2.
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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.
Mai Tone Lønnebakken, MD principal investigator
University of Bergen, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ST-Elevation Myocardial Infarction, run by University of Bergen at 1 site in Norway.
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 3 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 15 Jun 2025. 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 Norway. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122069, 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 15 Jun 2025.