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Salvage: Postconditioning With Adenosine for STEMI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University Hospital, Gasthuisberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00284323
First received: January 27, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Acute ST Elevation Myocardial Infarction
Drug: Adenosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

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

Estimated Enrollment: 100
Study Start Date: January 2006
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284323

Contacts
Contact: Walter JR Desmet, Ph.D. +3216332211 ext 43484 Walter.Desmet@uz.kuleuven.ac.be

Locations
Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: Walter JR Desmet, Ph.D.    +3216332211 ext 43484    Walter.Desmet@uz.kuleuven.ac.be   
Sub-Investigator: Christophe LF Dubois, M.D.         
Sub-Investigator: Peter R Sinnaeve, Ph.D.         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Walter JR Desmet, Ph.D. Universitaire Ziekenhuizen Leuven, Dept. of Cardiology
  More Information

No publications provided by University Hospital, Gasthuisberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00284323     History of Changes
Other Study ID Numbers: WD Salvage ML3181
Study First Received: January 27, 2006
Last Updated: January 27, 2006
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by University Hospital, Gasthuisberg:
Acute Myocardial Infarction
PCI
Adenosine
Postconditioning

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Adenosine
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014