Evaluation of Electromechanical Endocardial Mapping for Assessment of Myocardial Ischemia and Viability
FDG
+ NH(3)
Cardiovascular Diseases+1
+ Heart Diseases
+ Vascular Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.A novel left ventricular (LV) mapping system (Biosense, Inc.) uses low-intensity magnetic field energy to determine the location of sensor-tipped catheter electrodes within the LV. On the basis of previous experimental and human studies correlating the extent of myocardial ischemia with the amplitude of electrical signals, we hypothesize that such an integrated LV electromechanical mapping system could be used to distinguish healthy from ischemic or immobile myocardium on the basis of the extent of electromechanical endocardial signals. If this hypothesis is confirmed, the ability to detect on-line myocardial viability and ischemia in the catheterization laboratory may be feasible. The present study attempts to distinguish between ischemic, immobile, and normal myocardium by comparing LV electromechanical mapping data at rest and during pharmacologic stimulation, with imaging studies using MRI, PET, thallium and echo in patients with coronary artery disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.71 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Male or female patients greater than or equal to 21 years undergoing diagnostic cardiac catheterization. Must not have unstable angina. No significant unprotected left main disease (greater than 50% stenosis). No recent myocardial infarction (less than 4 weeks). Females must not be pregnant or lactating. No chronic atrial fibrillation. No prosthetic heart valves. No significant aortic valve pathology (sclerosis or stenosis) which might prevent retrograde crossing of catheter across the aortic valve. No left ventricular thrombus seen on echo. No severe heart failure (NYHA Class 4). No severe ectopy (greater than 1 every 10 beats) or ventricular tachycardia. No active infections (fever and elevated white cell count). Patients will not be considered for this protocol because of contraindications to MRI scan, as stated below: Pacemaker Implanted defibrillator Cerebral aneurysm clips Swan Ganz catheter with electrodes for a thermistor Cochlear implants Insulin pumps Neural stimulator
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps