Salvage: Postconditioning With Adenosine for STEMI

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

Detailed Description
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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).

Official Title
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Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)

Conditions
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Acute ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Adenosine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adenosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Acute Myocardial Infarction, Adenosine, Postconditioning