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:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT00799604
Eligibility Criteria:
Inclusion Criteria:
* Require elective cardiac operation involving the use of cardiopulmonary bypass
* Age 18 years or older
* A history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator
* Written informed consent
* Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial line
Exclusion Criteria:
* Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing
* Critical left main coronary artery stenosis
* Critical aortic valve (\<0.5 cm3) or mitral valve (\<1.0 cm3) stenosis
* Acute myocardial infarction within the prior 14 days
* Fully paced cardiac rhythm
* Known or suspected aortic dissection
* Requiring preoperative intra-aortic balloon pump counterpulsation therapy
* Contraindication to transesophageal echocardiography
* Positive pregnancy test or breast feeding
* Intolerance or allergy to calcium channel blockers
* Allergy to soybean oil or egg lecithin
* Any condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study
* Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00799604
Study Brief:
Protocol Section:
NCT00799604