Back to resultsSalvage: Postconditioning With Adenosine for STEMI
Primary Purpose
Acute ST Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Adenosine
Sponsored by
About this trial
This is an interventional treatment trial for Acute ST Elevation Myocardial Infarction focused on measuring Acute Myocardial Infarction, PCI, Adenosine, Postconditioning
Eligibility Criteria
Inclusion Criteria: Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes. ECG-criteria: ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block. Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity. Adequate vascular access seems possible (femoral pulsation palpable). Exclusion Criteria: Contra-indication to heparin, LMWH, clopidogrel. Anticipated difficulty with vascular access. Cardiogenic shock. Inability to give informed consent (or assent). High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole. Prior CABG. Participation in an investigational drug or device study within the past 30 days.
Sites / Locations
- Universitaire Ziekenhuizen LeuvenRecruiting
Outcomes
Primary Outcome Measures
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
By means of:
1. MR imaging
- at day 2-3: Rest perfusion, MVO, late enhancement and function
- at 4 months: Rest perfusion, late enhancement and function
2. Tissue Doppler Imaging
At 16-36 hours: Resolution of edema/wall thickness increase Function
At 4 months
3 Quantitative Coronary Angiography
TIMI flow grade, TIMI frame count on angiography of the IRA and myocardial blush grade before and at completion of the primary PCI procedure will be performed.
4 Electrocardiographic Analysis
- ST segment resolution will be assessed from the 12-lead ECG on admission and the ECG on admission on C.C.U. after the PCI-procedure. This will be examined for summed ST deviation and for ST deviation in the single lead with maximal ST-deviation on
Finally, the last ECG before hospital discharge and an ECG at 4 months will be studied for the evolution of Q-waves and T-waves.
- 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
5 Echocardiographic evaluation of left ventricular function
At 16-36 hours
After 4 months
6 Cardiac markers
Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
On admission
Before and after PCI, through the sheath
At 90 minutes after PCI
At 8 hours after PCI
At 16 hours after PCI
At 24 hours after PCI
7 Clinical follow-up
Occurrence of MACE (death, new Q-wave or non Q-wave MI or target vessel revascularisation) and the presence of clinical signs of heart failure will be recorded
At hospital discharge
At 30 days
At 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00284323
First Posted
January 27, 2006
Last Updated
January 27, 2006
Sponsor
University Hospital, Gasthuisberg
1. Study Identification
Unique Protocol Identification Number
NCT00284323
Brief Title
Salvage: Postconditioning With Adenosine for STEMI
Official Title
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Gasthuisberg
4. Oversight
5. Study Description
Brief Summary
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.
Detailed Description
Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (< 4 hours vs > 4 hours).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Elevation Myocardial Infarction
Keywords
Acute Myocardial Infarction, PCI, Adenosine, Postconditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Adenosine
Primary Outcome Measure Information:
Title
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
Title
By means of:
Title
1. MR imaging
Title
- at day 2-3: Rest perfusion, MVO, late enhancement and function
Title
- at 4 months: Rest perfusion, late enhancement and function
Title
2. Tissue Doppler Imaging
Title
At 16-36 hours: Resolution of edema/wall thickness increase Function
Title
At 4 months
Title
3 Quantitative Coronary Angiography
Title
TIMI flow grade, TIMI frame count on angiography of the IRA and myocardial blush grade before and at completion of the primary PCI procedure will be performed.
Title
4 Electrocardiographic Analysis
Title
- ST segment resolution will be assessed from the 12-lead ECG on admission and the ECG on admission on C.C.U. after the PCI-procedure. This will be examined for summed ST deviation and for ST deviation in the single lead with maximal ST-deviation on
Title
Finally, the last ECG before hospital discharge and an ECG at 4 months will be studied for the evolution of Q-waves and T-waves.
Title
- 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
Title
5 Echocardiographic evaluation of left ventricular function
Title
At 16-36 hours
Title
After 4 months
Title
6 Cardiac markers
Title
Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
Title
On admission
Title
Before and after PCI, through the sheath
Title
At 90 minutes after PCI
Title
At 8 hours after PCI
Title
At 16 hours after PCI
Title
At 24 hours after PCI
Title
7 Clinical follow-up
Title
Occurrence of MACE (death, new Q-wave or non Q-wave MI or target vessel revascularisation) and the presence of clinical signs of heart failure will be recorded
Title
At hospital discharge
Title
At 30 days
Title
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
ECG-criteria: ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
Adequate vascular access seems possible (femoral pulsation palpable).
Exclusion Criteria:
Contra-indication to heparin, LMWH, clopidogrel.
Anticipated difficulty with vascular access.
Cardiogenic shock.
Inability to give informed consent (or assent).
High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
Prior CABG.
Participation in an investigational drug or device study within the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walter JR Desmet, Ph.D.
Phone
+3216332211
Ext
43484
Email
Walter.Desmet@uz.kuleuven.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter JR Desmet, Ph.D.
Organizational Affiliation
Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter JR Desmet, Ph.D.
Phone
+3216332211
Ext
43484
Email
Walter.Desmet@uz.kuleuven.ac.be
First Name & Middle Initial & Last Name & Degree
Christophe LF Dubois, M.D.
First Name & Middle Initial & Last Name & Degree
Peter R Sinnaeve, Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21196444
Citation
Desmet W, Bogaert J, Dubois C, Sinnaeve P, Adriaenssens T, Pappas C, Ganame J, Dymarkowski S, Janssens S, Belmans A, Van de Werf F. High-dose intracoronary adenosine for myocardial salvage in patients with acute ST-segment elevation myocardial infarction. Eur Heart J. 2011 Apr;32(7):867-77. doi: 10.1093/eurheartj/ehq492. Epub 2010 Dec 31.
Results Reference
derived
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