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Salvage: Postconditioning With Adenosine for STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284323
Recruitment Status : Unknown
Verified January 2006 by University Hospital, Gasthuisberg.
Recruitment status was:  Recruiting
First Posted : January 31, 2006
Last Update Posted : January 31, 2006
Information provided by:
University Hospital, Gasthuisberg

Brief Summary:
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.

Condition or disease Intervention/treatment Phase
Acute ST Elevation Myocardial Infarction Drug: Adenosine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Adenosine

Primary Outcome Measures :
  1. Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
  2. By means of:
  3. 1. MR imaging
  4. - at day 2-3: Rest perfusion, MVO, late enhancement and function
  5. - at 4 months: Rest perfusion, late enhancement and function
  6. 2. Tissue Doppler Imaging
  7. At 16-36 hours: Resolution of edema/wall thickness increase Function
  8. At 4 months
  9. 3 Quantitative Coronary Angiography
  10. 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.
  11. 4 Electrocardiographic Analysis
  12. - 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
  13. 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.
  14. - 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
  15. 5 Echocardiographic evaluation of left ventricular function
  16. At 16-36 hours
  17. After 4 months
  18. 6 Cardiac markers
  19. Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
  20. On admission
  21. Before and after PCI, through the sheath
  22. At 90 minutes after PCI
  23. At 8 hours after PCI
  24. At 16 hours after PCI
  25. At 24 hours after PCI
  26. 7 Clinical follow-up
  27. 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
  28. At hospital discharge
  29. At 30 days
  30. At 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284323

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Contact: Walter JR Desmet, Ph.D. +3216332211 ext 43484

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Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: Walter JR Desmet, Ph.D.    +3216332211 ext 43484   
Sub-Investigator: Christophe LF Dubois, M.D.         
Sub-Investigator: Peter R Sinnaeve, Ph.D.         
Sponsors and Collaborators
University Hospital, Gasthuisberg
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Principal Investigator: Walter JR Desmet, Ph.D. Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00284323    
Other Study ID Numbers: WD Salvage ML3181
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: January 31, 2006
Last Verified: January 2006
Keywords provided by University Hospital, Gasthuisberg:
Acute Myocardial Infarction
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action