Salvage: Postconditioning With Adenosine for STEMI

Acute ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00284323
• Other study ID #: WD Salvage ML3181
• Status: Recruiting
• Phase: Phase 2
• First received: January 27, 2006
• Last updated: January 27, 2006
• Start date: January 2006

Study information

• Verified date: January 2006
• Source: University Hospital, Gasthuisberg
• Contact: Walter JR Desmet, Ph.D.
• Phone: +3216332211
• Email: Walter.Desmet[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute ST Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Adenosine

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

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