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 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT01004406
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide informed consent (including HIPAA)
* Age \>30 years
* Presenting with acute coronary syndrome (ACS), manifested as unstable angina or non-ST-elevation myocardial infarction
* Referred for clinically-indicated, non-emergent (the procedure is not required to be performed within 3 hours after patient presentation) coronary angiography and PCI with IVUS-VH of target coronary artery for ACS
* Successful placement of two large bore IV cannulas in bilateral upper extremities
* Fasting (\>= 12 hours) LDL \>= 100mg/dl while on \<= 80mg Atorvastatin or equivalent dose of other statin, performed at time of admission or 3 months prior to PCI.
Exclusion Criteria:
* Known allergy to aspirin, clopidogrel, statins, or iodinated contrast
* Positive pregnancy test, planning to become pregnant, or breast-feeding
* Coexisting conditions that limit life expectancy to less than six months or affect patient compliance
* Uncontrolled fasting (\>= 12 hours) triglyceride levels (\>= 500mg/dl)
* Already participating in an investigational device or drug study
* History of heparin induced thrombocytopenia (HIT)
* Persons with estimated glomerular filtration rate (eGFR) less than 60 ml/min if they are diabetic; persons with eGFR of less than 45 ml/min if they are not diabetic
* ST-elevation myocardial infarction at admission
* Abnormal liver function test (LFT) at time of admission or 3 month prior to PCI with abnormal LFT defined as any liver transaminases (ALT or AST) 3 times the upper limit of the normal laboratory reference
* Pre-PCI or post-PCI left ventricular ejection fraction \<25% by echo or cardiac catheterization done after admission
* Pre-PCI, intra-PCI, or post-PCI hemodynamic instability with hypotension
* Pre-PCI, intra-PCI, or post-PCI cardiac arrest
* Pre-PCI or post-PCI heart failure with or without pulmonary edema
* Intra-PCI or post-PCI sustained ventricular tachycardia
* Complicated PCI, defined as PCI with any of the vascular access complications (large hematoma with lump \> 5 cm or requiring medical treatment; arteriovenous (AV) fistula; pseudo aneurysm requiring treatment; retroperitoneal bleeding), or PCI with any of the procedural complications (abrupt vessel closure; no-reflow phenomenon; new angiographic thrombus; new major dissection with reduced flow; catheter-related thrombus), or PCI requiring further medical treatments (urgent coronary artery bypass grafting (CABG); endotracheal intubation; unplanned in-aortic balloon pump; left ventricular assist device (LVAD); covered stent; unplanned temporary pacemaker wire; administration of inotropes; CPR) , or PCI resulting in clinical events (death; stroke; myocardial infarction; stent thrombosis) during or within 24 hours after the index PCI
* Post-PCI ongoing chest pain
* Post-PCI severe groin pain and hematoma \> 5cm in diameter
* Persons whose hemoglobin is less than 9 grams following the index PCI/IVUS procedure, or who experience a drop in hemoglobin of greater than or equal to 2 grams following the procedure
* Not able to comply with study protocol as determined by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Years
Study:
NCT01004406
Study Brief:
Protocol Section:
NCT01004406