Salvage: Postconditioning With Adenosine for STEMI

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Unknown status

CT.gov ID

NCT00284323

Collaborator

(none)

100

Enrollment

Location

Study Details

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.

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).

Study Design

Study Type:

Interventional

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 :

Jan 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.