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Electromechanical Mapping to Evaluate Heart Muscle

Primary Purpose

Myocardial Ischemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FDG
NH(3)
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring Electromechanical Mapping, Myocardial Viability, Myocardial Ischemia, Positron Emission Tomography, Magnetic Resonance Imaging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001895
Brief Title
Electromechanical Mapping to Evaluate Heart Muscle
Official Title
Evaluation of Electromechanical Endocardial Mapping for Assessment of Myocardial Ischemia and Viability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment. When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop. Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Electromechanical Mapping, Myocardial Viability, Myocardial Ischemia, Positron Emission Tomography, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
71 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FDG
Intervention Type
Drug
Intervention Name(s)
NH(3)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
665778
Citation
Heyndrickx GR, Baig H, Nellens P, Leusen I, Fishbein MC, Vatner SF. Depression of regional blood flow and wall thickening after brief coronary occlusions. Am J Physiol. 1978 Jun;234(6):H653-9. doi: 10.1152/ajpheart.1978.234.6.H653.
Results Reference
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PubMed Identifier
1607518
Citation
Perrone-Filardi P, Bacharach SL, Dilsizian V, Maurea S, Marin-Neto JA, Arrighi JA, Frank JA, Bonow RO. Metabolic evidence of viable myocardium in regions with reduced wall thickness and absent wall thickening in patients with chronic ischemic left ventricular dysfunction. J Am Coll Cardiol. 1992 Jul;20(1):161-8. doi: 10.1016/0735-1097(92)90153-e.
Results Reference
background
PubMed Identifier
2362606
Citation
Dilsizian V, Rocco TP, Freedman NM, Leon MB, Bonow RO. Enhanced detection of ischemic but viable myocardium by the reinjection of thallium after stress-redistribution imaging. N Engl J Med. 1990 Jul 19;323(3):141-6. doi: 10.1056/NEJM199007193230301.
Results Reference
background

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Electromechanical Mapping to Evaluate Heart Muscle

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