NCT00291174

Brief 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. 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

February 10, 2006

Last Update Submit

August 15, 2016

Conditions

Keywords

Ventricular ArrhythmiaMyocardial InfarctionVentricular DysfunctionCoronary Artery DiseaseStructural Heart DiseaseArrhythmiaCardiomyopathies

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective cardiac surgery for coronary artery disease

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (17)

  • 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.

    PMID: 8743758BACKGROUND
  • 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.

    PMID: 15145109BACKGROUND
  • 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.

    PMID: 14521672BACKGROUND
  • Zarowitz BJ, Pilla AM. Bioelectrical impedance in clinical practice. DICP. 1989 Jul-Aug;23(7-8):548-55. doi: 10.1177/1060028089023007-803.

    PMID: 2669371BACKGROUND
  • 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.

    PMID: 10372149BACKGROUND
  • 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.

    PMID: 9386178BACKGROUND
  • 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.

    PMID: 9876322BACKGROUND
  • 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.

    PMID: 3689045BACKGROUND
  • 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.

    PMID: 8419008BACKGROUND
  • 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.

    PMID: 3621491BACKGROUND
  • 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.

    PMID: 15311828BACKGROUND
  • 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.

    PMID: 15535176BACKGROUND
  • 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.

    PMID: 10490477BACKGROUND
  • 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.

    PMID: 10962753BACKGROUND
  • 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.

    PMID: 11123232BACKGROUND
  • 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. doi: 10.1016/s0735-1097(01)01209-8.

    PMID: 11345370BACKGROUND
  • 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. doi: 10.1088/0967-3334/26/2/013. Epub 2005 Mar 29.

    PMID: 15798226BACKGROUND

MeSH Terms

Conditions

CardiomyopathiesVentricular DysfunctionMyocardial InfarctionArrhythmias, CardiacCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • David J. Callans, MD

    University of Pennsylvania, Dept of Medicine, Cardiology Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2006

Study Completion

January 1, 2008

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations