Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT00317512
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00317512
Study Brief:
Protocol Section:
NCT00317512