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Measuring Electrical Resistance of Different Tissues on the Outer Surface of the Heart
This study has been terminated.
Sponsors and Collaborators: University of Pennsylvania
Biosense Webster, Inc.
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00291174
  Purpose

This is a research study to evaluate the electrical properties of heart tissue. The purpose of this study is to determine the impedance (electrical resistance) of different tissues on the outer surface of the heart. This may be important for distinguishing scarred heart muscle from fat that can be seen on the surface of the heart. This information may eventually be utilized in patients that undergo a procedure (called catheter ablation) for the treatment of life-threatening heart rhythms. Investigators expect a detectable difference between the impedance of normal and infarcted myocardium (approximately 50 ohms).


Condition
Cardiomyopathies
Ventricular Dysfunction
Myocardial Infarction
Arrhythmia

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia Cardiomyopathy Heart Attack Scars
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Impedance Measurement of Epicardial Substrate for Ventricular Arrhythmias: Case Control Series of Patients With and Without Myocardial Scarring

Further study details as provided by University of Pennsylvania:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: April 2006
Study Completion Date: January 2008
Detailed Description:

The treatment of cardiac arrhythmias with endocardial catheter ablation has evolved rapidly over the past few decades. At the time of this writing, the ablation of almost all atrial and ventricular arrhythmias has been described in the literature. Multiple energy modalities (e.g. radiofrequency, cryotherapy) and approaches (e.g. retrograde aortic, transseptal puncture) have been described, yet ablation of some rhythms is not as successful as others.

The realization that ventricular tachycardia (VT) in the setting of Chagas Disease can originate in the epicardium has lead to the development of a percutaneous, transthoracic epicardial approach to mapping and ablation of this arrhythmia. This approach has now been applied to patients with VT in the setting of ischemic and nonischemic heart disease at many centers throughout the world. Traditional mapping technologies are utilized on the epicardium to define scarred heart tissue and locate the VT circuit.

It is well known that human hearts display a variable amount of fat overlying the epicardium. Not only is the coronary vasculature embedded in a layer of adipose tissue, but the rest of the heart may have areas of epicardial fat. As fat is an insulator and does not generate or easily conduct electrical activity, current mapping techniques may classify epicardial fat incorrectly as myocardial scar. This may have important effects on the ability to diagnose and treat arrhythmias with epicardial ablation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients undergoing elective cardiac surgery for coronary artery disease

Criteria

Inclusion Criteria:

  • All adult patients undergoing elective cardiac surgery for coronary artery disease (with or without normal heart function) or valvular disease (with normal heart function) at the Hospital of the University of Pennsylvania under the direction of Y. Joseph Woo MD will be eligible.

Exclusion Criteria:

  • Patients undergoing emergent surgery and patients with idiopathic cardiomyopathy, infiltrative cardiomyopathies and hypertrophic cardiomyopathies will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291174

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Biosense Webster, Inc.
Investigators
Principal Investigator: David J. Callans, MD University of Pennsylvania, Dept of Medicine, Cardiology Division
  More Information

Publications:
Sosa E, Scanavacca M, d'Avila A, Pilleggi F. A new technique to perform epicardial mapping in the electrophysiology laboratory. J Cardiovasc Electrophysiol. 1996 Jun;7(6):531-6.
Soejima K, Stevenson WG, Sapp JL, Selwyn AP, Couper G, Epstein LM. Endocardial and epicardial radiofrequency ablation of ventricular tachycardia associated with dilated cardiomyopathy: the importance of low-voltage scars. J Am Coll Cardiol. 2004 May 19;43(10):1834-42.
Dixit S, Narula N, Callans DJ, Marchlinski FE. Electroanatomic mapping of human heart: epicardial fat can mimic scar. J Cardiovasc Electrophysiol. 2003 Oct;14(10):1128. No abstract available.
Zarowitz BJ, Pilla AM. Bioelectrical impedance in clinical practice. DICP. 1989 Jul-Aug;23(7-8):548-55. Review.
Casas O, Bragos R, Riu PJ, Rosell J, Tresanchez M, Warren M, Rodriguez-Sinovas A, Carreno A, Cinca J. In vivo and in situ ischemic tissue characterization using electrical impedance spectroscopy. Ann N Y Acad Sci. 1999 Apr 20;873:51-8.
Cinca J, Warren M, Carreno A, Tresanchez M, Armadans L, Gomez P, Soler-Soler J. Changes in myocardial electrical impedance induced by coronary artery occlusion in pigs with and without preconditioning: correlation with local ST-segment potential and ventricular arrhythmias. Circulation. 1997 Nov 4;96(9):3079-86.
Cinca J, Warren M, Rodriguez-Sinovas A, Tresanchez M, Carreno A, Bragos R, Casas O, Domingo A, Soler-Soler J. Passive transmission of ischemic ST segment changes in low electrical resistance myocardial infarct scar in the pig. Cardiovasc Res. 1998 Oct;40(1):103-12.
Ellenby MI, Small KW, Wells RM, Hoyt DJ, Lowe JE. On-line detection of reversible myocardial ischemic injury by measurement of myocardial electrical impedance. Ann Thorac Surg. 1987 Dec;44(6):587-97.
Fallert MA, Mirotznik MS, Downing SW, Savage EB, Foster KR, Josephson ME, Bogen DK. Myocardial electrical impedance mapping of ischemic sheep hearts and healing aneurysms. Circulation. 1993 Jan;87(1):199-207.
Kleber AG, Riegger CB, Janse MJ. Electrical uncoupling and increase of extracellular resistance after induction of ischemia in isolated, arterially perfused rabbit papillary muscle. Circ Res. 1987 Aug;61(2):271-9.
Salazar Y, Bragos R, Casas O, Cinca J, Rosell J. Transmural versus nontransmural in situ electrical impedance spectrum for healthy, ischemic, and healed myocardium. IEEE Trans Biomed Eng. 2004 Aug;51(8):1421-7.
Salazar Y, Cinca J, Rosell-Ferrer J. Effect of electrode locations and respiration in the characterization of myocardial tissue using a transcatheter impedance method. Physiol Meas. 2004 Oct;25(5):1095-103.
Schwartzman D, Chang I, Michele JJ, Mirotznik MS, Foster KR. Electrical impedance properties of normal and chronically infarcted left ventricular myocardium. J Interv Card Electrophysiol. 1999 Oct;3(3):213-24.
Warren M, Bragos R, Casas O, Rodriguez-Sinovas A, Rosell J, Anivarro I, Cinca J. Percutaneous electrocatheter technique for on-line detection of healed transmural myocardial infarction. Pacing Clin Electrophysiol. 2000 Aug;23(8):1283-7.
Wolf T, Gepstein L, Hayam G, Zaretzky A, Shofty R, Kirshenbaum D, Uretzky G, Oron U, Ben-Haim SA. Three-dimensional endocardial impedance mapping: a new approach for myocardial infarction assessment. Am J Physiol Heart Circ Physiol. 2001 Jan;280(1):H179-88.
Wolf T, Gepstein L, Dror U, Hayam G, Shofti R, Zaretzky A, Uretzky G, Oron U, Ben-Haim SA. Detailed endocardial mapping accurately predicts the transmural extent of myocardial infarction. J Am Coll Cardiol. 2001 May;37(6):1590-7.
Zhu F, Leonard EF, Levin NW. Body composition modeling in the calf using an equivalent circuit model of multi-frequency bioimpedance analysis. Physiol Meas. 2005 Apr;26(2):S133-43. Epub 2005 Mar 29.

Study ID Numbers: 803272
Study First Received: February 10, 2006
Last Updated: March 4, 2008
ClinicalTrials.gov Identifier: NCT00291174  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Ventricular Arrhythmia
Myocardial Infarction
Ventricular Dysfunction
Coronary Artery Disease
Structural Heart Disease
Arrhythmia
Cardiomyopathies

Study placed in the following topic categories:
Ventricular Dysfunction
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Cardiomyopathies
Coronary Disease
Necrosis
Infarction
Myocardial Infarction
Coronary Artery Disease
Arrhythmias, Cardiac
Cicatrix

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009