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CardiomyopathiesNCT00291174

Measuring Electrical Resistance of Different Tissues on the Outer Surface of the Heart

An observational study of Cardiomyopathies and Ventricular Dysfunction, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
8 participants
Where
1 siteUnited States
Study dates
Apr 2006to Jan 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients undergoing elective cardiac surgery for coronary artery disease

Who may be able to join

  • 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.

Who cannot join

  • Patients undergoing emergent surgery and patients with idiopathic cardiomyopathy, infiltrative cardiomyopathies and hypertrophic cardiomyopathies will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Impedance Measurement of Epicardial Substrate for Ventricular Arrhythmias: Case Control Series of Patients With and Without Myocardial Scarring

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).

Read the 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.

Keywords
Ventricular Arrhythmia, Myocardial Infarction, Ventricular Dysfunction, Coronary Artery Disease, Structural Heart Disease, Arrhythmia, Cardiomyopathies
Medical subject headings
Cardiomyopathies, Ventricular Dysfunction, Myocardial Infarction, Arrhythmias, Cardiac, Coronary Artery Disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJul 2006
  4. Study completionJan 2008

Why it stopped: Unforeseen difficulty identifying and enrolling eligible subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291174
Sponsor's protocol ID
803272
Status last verified
Aug 2016
First submitted
10 Feb 2006
Last updated
16 Aug 2016
Results posted
No

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. doi: 10.1111/j.1540-8167.1996.tb00559.x.

    PubMed 8743758

  • 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. doi: 10.1016/j.jacc.2004.01.029.

    PubMed 15145109

  • 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. doi: 10.1046/j.1540-8167.2003.03138.x. No abstract available.

    PubMed 14521672

  • Zarowitz BJ, Pilla AM. Bioelectrical impedance in clinical practice. DICP. 1989 Jul-Aug;23(7-8):548-55. doi: 10.1177/1060028089023007-803.

    PubMed 2669371

  • 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. doi: 10.1111/j.1749-6632.1999.tb09448.x.

    PubMed 10372149

  • 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. doi: 10.1161/01.cir.96.9.3079.

    PubMed 9386178

  • 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. doi: 10.1016/s0008-6363(98)00145-x.

    PubMed 9876322

  • 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. doi: 10.1016/s0003-4975(10)62141-8.

    PubMed 3689045

  • 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. doi: 10.1161/01.cir.87.1.199.

    PubMed 8419008

  • 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. doi: 10.1161/01.res.61.2.271.

    PubMed 3621491

  • 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. doi: 10.1109/TBME.2004.828030.

    PubMed 15311828

  • 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. doi: 10.1088/0967-3334/25/5/001.

    PubMed 15535176

  • 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. doi: 10.1023/a:1009887306055.

    PubMed 10490477

  • 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. doi: 10.1111/j.1540-8159.2000.tb00945.x.

    PubMed 10962753

  • 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. doi: 10.1152/ajpheart.2001.280.1.H179.

    PubMed 11123232

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathies and Ventricular Dysfunction, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unforeseen difficulty identifying and enrolling eligible subjects). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291174, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.

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