Magnetocardiography (MCG) in the Diagnosis of Chest Pain Syndrome

NCT00572949 | Withdrawn

• 1 other identifier: 4039
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate a better way of diagnosing heart artery disease, heart attack and damage to the heart muscle early on. Currently, it often takes several hours after admission before lab tests will show that there has been any damage to the heart muscle. Although the standard electrocardiogram is quick and non-painful it may miss many cases of significant coronary heart disease. The investigators are proposing that a new entirely non-contact tool, the Magnetocardiograph (MCG), with high accuracy is able to predict the presence of significant coronary heart disease early on before other studies become positive. The investigators hope by this that the investigators can develop an algorithm for better triage and management of patients with chest pain. This research study is designed to test the effectiveness of the investigational use of the Magnetocardiograph (MCG) that has been approved by the U.S Food and Drug Administration (FDA). While the MCG used in the study is FDA-approved as a tool for the non-contact measurement and display of the magnetic fields of the heart generated by the electrical currents, it is not yet approved for the specific diagnosis of heart artery disease (ischemia).

Conditions

Chest Pain

Keywords

heart disease; chest pain; coronary artery disease; atherosclerosis

Study Arms (1)

1

Patients with chest pain syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chest pain syndrome

You may qualify if:

• Patients with chest pain syndrome

You may not qualify if:

• ST elevation MI
• Hemodynamically unstable patients
• Tachycardia with heart rate \>150 just prior to testing or at time of testing
• A-V Dissociation on 12-lead ECG
• Patients with pacemakers or internal defibrillators
• Minors \< 18 years of age
• Patients unable to lie flat for the examination

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• CardioMag Imaging: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (6)

• 1) Cohen D, Edelsack EA, Zimmerman JE. Magnetocardiograms taken inside a shielded room with a superconducting point-contact magnetometer. Appl. Phys. Lett. 1970, 16, 278-280.

  BACKGROUND

• Nakaya Y, Sumi M, Saito K, Fujino K, Murakami M, Mori H. Analysis of current source of the heart using isomagnetic and vector arrow maps. Jpn Heart J. 1984 Sep;25(5):701-11. doi: 10.1536/ihj.25.701.

  PMID: 6239932 BACKGROUND

• 3) Stroink G, MacAuley C, Montague TJ, Horacek BM. Normal and abnormal components in magnetocardiographic maps of a subject with myocardial infarction. Med. Biol. Eng. Comp. 1985, 23, 61-62.

  BACKGROUND

• 4) Brazdeikis A, Taylor AA, Mahmarian JJ, Xue Y, Chu CW. Comparison of magnetocardiograms acquired in unshielded clinical environment at rest, during and after exercise and in conjunction with myocardial perfusion imaging. Biomag 2002, 530-532.

  BACKGROUND

• 5) Chaikovsky I, Primin M, Nedayvoda I, Vassylyev V, Sosnitsky V, Steinberg F. Computerized classification of patients with coronary artery disease but normal or unspecifically changed ECG and healthy volunteers. Biomag 2002, 534-536.

  BACKGROUND

• Morguet AJ, Behrens S, Kosch O, Lange C, Zabel M, Selbig D, Munz DL, Schultheiss HP, Koch H. Myocardial viability evaluation using magnetocardiography in patients with coronary artery disease. Coron Artery Dis. 2004 May;15(3):155-62. doi: 10.1097/00019501-200405000-00004.

  PMID: 15096996 BACKGROUND

MeSH Terms

Conditions

Chest Pain; Heart Diseases; Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kirsten Tolstrup, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: October 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 17, 2009

Record last verified: 2009-11

Locations

US (1)