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ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI) (IDEAL NSTEMI)

Primary Purpose

Non-ST-elevation Myocardial Infarction

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
immediate angiography and revascularization
early invasive angiography
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST-elevation Myocardial Infarction focused on measuring Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NSTEMI with

    • ischemic symptoms >10 minutes within 24 h
    • elevated troponin or creatine kinase above the upper limit of normal
    • ST-segment depression or transient ST-segment elevation, T-wave inversion
    • informed consent.

Exclusion Criteria:

  • Age < 18 years
  • Age > 90 years
  • persistent angina
  • hemodynamic instability
  • overt congestive heart failure
  • life-threatening arrhythmias
  • STEMI
  • limited life-expectancy < 6 months
  • chronic oral anticoagulation
  • fibrinolysis < 48 hours
  • PCI < 14 days
  • contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
  • recent major trauma or surgery

Sites / Locations

  • University of Leipzig - Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immediate angiography

early invasive angiography

Arm Description

Immediate invasive angiography < 2 h after randomization

early invasive angiography 12-72 h after randomization

Outcomes

Primary Outcome Measures

Death and non-fatal recurrent infarction

Secondary Outcome Measures

Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization

Full Information

First Posted
August 6, 2009
Last Updated
July 3, 2018
Sponsor
University of Leipzig
Collaborators
Stiftung Institut fuer Herzinfarktforschung
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1. Study Identification

Unique Protocol Identification Number
NCT00954668
Brief Title
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
Acronym
IDEAL NSTEMI
Official Title
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
January 1, 2009 (Actual)
Study Completion Date
January 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
Stiftung Institut fuer Herzinfarktforschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST-elevation Myocardial Infarction
Keywords
Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immediate angiography
Arm Type
Experimental
Arm Description
Immediate invasive angiography < 2 h after randomization
Arm Title
early invasive angiography
Arm Type
Active Comparator
Arm Description
early invasive angiography 12-72 h after randomization
Intervention Type
Procedure
Intervention Name(s)
immediate angiography and revascularization
Intervention Description
immediate angiography < 2 hours after randomization
Intervention Type
Procedure
Intervention Name(s)
early invasive angiography
Intervention Description
early invasive angiography 12-72 h after randomization
Primary Outcome Measure Information:
Title
Death and non-fatal recurrent infarction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization
Time Frame
6 months

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: NSTEMI with ischemic symptoms >10 minutes within 24 h elevated troponin or creatine kinase above the upper limit of normal ST-segment depression or transient ST-segment elevation, T-wave inversion informed consent. Exclusion Criteria: Age < 18 years Age > 90 years persistent angina hemodynamic instability overt congestive heart failure life-threatening arrhythmias STEMI limited life-expectancy < 6 months chronic oral anticoagulation fibrinolysis < 48 hours PCI < 14 days contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel recent major trauma or surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Uwe Zeymer, MD
Organizational Affiliation
Institut für Herzinfarktforschung
Official's Role
Study Director
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)

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