Back to resultsIncidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
Primary Purpose
NSTEMI
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for NSTEMI focused on measuring myocardial infarction, coronary occlusion, myocardial revascularization, collaterals, prognosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- University of Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
occluded culprit artery
non-occluded culprit artery
Arm Description
An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Outcomes
Primary Outcome Measures
MACE
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
Secondary Outcome Measures
CK and CK-MB
Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01159366
Brief Title
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
Official Title
Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSTEMI
Keywords
myocardial infarction, coronary occlusion, myocardial revascularization, collaterals, prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
602 (Actual)
8. Arms, Groups, and Interventions
Arm Title
occluded culprit artery
Arm Type
Active Comparator
Arm Description
An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
Arm Title
non-occluded culprit artery
Arm Type
Active Comparator
Arm Description
A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Other Intervention Name(s)
early invasive treatment strategy in NSTEMI
Intervention Description
early timing
Primary Outcome Measure Information:
Title
MACE
Description
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
Time Frame
6 months
Secondary Outcome Measure Information:
Title
CK and CK-MB
Description
Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, MD, PhD
Organizational Affiliation
University of Leipzig
Official's Role
Study Chair
Facility Information:
Facility Name
University of Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
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