Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Angina Pectoris, Unstable Angina, Myocardial Infarction
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring Hemoglobin Based Oxygen carrier, HBOC 201, Percutaneous Revascularization, Percutaneous Coronary Intervention, Non ST-segment Elevation Myocardial Infarction, Tissue Oxygenation, Transluminal Percutaneous Coronary Angioplasty
Eligibility Criteria
Inclusion Criteria: Written informed consent provided before initiation of any study-related procedure, and before any pre-procedural sedation, and agreement to comply with all protocol-specified procedures Acute Coronary Syndrome (Stable and unstable angina or non ST segment Elevation Myocardial Infarction (UA/non-STEMI) [Braunwald class I-III Class B], Appendix 1). Single vessel disease of the Left Coronary Artery (LCA) One vessel disease of the Right Coronary Artery (RCA) Have a single de novo lesion Older than 18 years and younger than 75 years of age Eligible to undergo PCI on the target vessel Exclusion Criteria: Previous Q-wave myocardial infarction Congestive heart failure with Left ventricular Ejection Fraction <35% Confirmed pregnancy Anemia to a hemoglobin level <8.5g/dl Systemic mastocytosis History of known haemorrhagic stroke at any time or any stroke less than or equal to 30 days prior to randomization Severe hypertension (>180/110mmHG) not adequately controlled by antihypertensive therapy at time of study entry Need for mechanical ventilation Renal impairment: Creatinine > 1.6mg/dl Known history of COPD with FEV 1s < 1.0 liter Contra-indications to the use of adenosine, i.e.History of bronchospasm and/or ongoing therapy with theophylline derivatives, >1 degree atrioventricular block in the absence of a functioning electronic pacemaker and treatment with dipyridamole within the prior 24 hours Patients with significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support or pulmonary edema History of or clinical documentation of severe aortic/mitral valve stenosis, significant aortic valve insufficiency Participation in another trial with an investigational drug or device (of other investigations) including the follow-up period, within the last 30 days before enrollment Inability or unwillingness to perform 30 day follow up Concomitant disease that interferes with prognosis (life expectancy of less than or equal to 6 months Contra-indications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye Patient weight > 110kg
Sites / Locations
- Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
- Site # 6 Antwerpen
- Site # 2 Herzzentrum
- Site # 3 OLVG Amsterdam
- Site # 4 Academisch Medisch Centrum (AMC)
- Site # 1 Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
1
2
3
Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by HBOC-201 at 7.7 ml/min over 15 minutes