Clinical trial NCT00284323: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute ST Elevation Myocardial Infarction
Keywords: Acute Myocardial Infarction
PCI
Adenosine
Postconditioning
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
measure: By means of:
measure: 1. MR imaging
measure: - at day 2-3: Rest perfusion, MVO, late enhancement and function
measure: - at 4 months: Rest perfusion, late enhancement and function
measure: 2. Tissue Doppler Imaging
measure: At 16-36 hours: Resolution of edema/wall thickness increase Function
measure: At 4 months
measure: 3 Quantitative Coronary Angiography
measure: 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.
measure: 4 Electrocardiographic Analysis
measure: - 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
measure: 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.
measure: - 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
measure: 5 Echocardiographic evaluation of left ventricular function
measure: At 16-36 hours
measure: After 4 months
measure: 6 Cardiac markers
measure: Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
measure: On admission
measure: Before and after PCI, through the sheath
measure: At 90 minutes after PCI
measure: At 8 hours after PCI
measure: At 16 hours after PCI
measure: At 24 hours after PCI
measure: 7 Clinical follow-up
measure: 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
measure: At hospital discharge
measure: At 30 days
measure: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
name: Walter JR Desmet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.