NCT00284323

Brief Summary

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
Last Updated

January 31, 2006

Status Verified

January 1, 2006

First QC Date

January 27, 2006

Last Update Submit

January 27, 2006

Conditions

Acute ST Elevation Myocardial Infarction

Keywords

Acute Myocardial InfarctionPCIAdenosinePostconditioning

Outcome Measures

Primary Outcomes (30)

  • 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

Interventions

AdenosineDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Adequate vascular access seems possible (femoral pulsation palpable).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21196444DERIVED

MeSH Terms

Interventions

Adenosine

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Walter JR Desmet, Ph.D.

    Universitaire Ziekenhuizen Leuven, Dept. of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter JR Desmet, Ph.D.

CONTACT

+3216332211Walter.Desmet@uz.kuleuven.ac.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

January 1, 2006

Last Updated

January 31, 2006

Record last verified: 2006-01

Locations

BE(1)