NSTEMIPhase 4NCT01159366
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
A Phase 4 study testing percutaneous coronary intervention in people with NSTEMI, run by University of Jena at 1 site in Germany.
Trial summary
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- NSTEMI
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Jan 2010
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 90 years,
- onset of angina pectoris at rest <24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting <24 h,
- elevated troponin T ≥0.03 µg/L and
- written informed consent.
Who cannot join
- persistent angina,
- ST-segment elevation myocardial infarction (STEMI),
- hemodynamic instability including cardiogenic shock,
- oral anticoagulation therapy,
- contraindications for glycoprotein IIb/IIIa inhibitors,
- other disease with life expectancy <6 months,
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- known coagulopathy,
- pregnancy,
- other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
- no ability to consent, and
- participation in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.
Read the detailed description
We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.
- Conditions
- NSTEMI
- Being tested
- percutaneous coronary intervention
- Keywords
- myocardial infarction, coronary occlusion, myocardial revascularization, collaterals, prognosis
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Myocardial Infarction, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
Also called early invasive treatment strategy in NSTEMI
early timing
| Study group | Role | What they receive |
|---|---|---|
| occluded culprit artery | Active comparator | An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1. Receives: Procedure: percutaneous coronary intervention |
| non-occluded culprit artery | Active comparator | A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1. Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
Measured: 6 months
Secondary outcomes (1)
CK and CK-MB
Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMIStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Schuler, MD, PhD, Study chair, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159366
- Sponsor's protocol ID
- NCT00402675
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
- ClinicalTrials.gov ID
- NCT01159366
- Acronym / sponsor ID
- NCT00402675
- Conditions
- NSTEMI
- Keywords
- myocardial infarction, coronary occlusion, myocardial revascularization, collaterals, prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Jul 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.
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.
Detailed description
We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occluded culprit artery | Active comparator | Procedure: percutaneous coronary interventionAn occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1. |
| non-occluded culprit artery | Active comparator | Procedure: percutaneous coronary interventionA non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 90 years,
- onset of angina pectoris at rest <24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting <24 h,
- elevated troponin T ≥0.03 µg/L and
- written informed consent.
Key exclusion criteria (11 listed)
- persistent angina,
- ST-segment elevation myocardial infarction (STEMI),
- hemodynamic instability including cardiogenic shock,
- oral anticoagulation therapy,
- contraindications for glycoprotein IIb/IIIa inhibitors,
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 |
|---|---|---|
| percutaneous coronary interventionAlso: early invasive treatment strategy in NSTEMIearly timing | Procedure or surgery | non-occluded culprit artery, occluded culprit artery |
Primary outcome
MACE
Time frame: 6 months
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
1 secondary outcome
CK and CK-MB
Time frame: 48 hours
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 Jul 2010.
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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.
Gerhard Schuler, MD, PhD study chair
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing percutaneous coronary intervention in people with NSTEMI, run by University of Jena at 1 site in Germany.
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 11 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 Jul 2010. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MACE (time frame: 6 months). 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 12 Jul 2010.