Novel Method to Diagnose Acute Myocardial Ischemia

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00285922
First received: January 31, 2006
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

The aim of this study is to improve the detection of heart attack in people who come to a hospital emergency room (ER) with cardiac symptoms. We are testing a novel technology that calculates the heart's electrical activity at points all around the upper body torso and develops a map showing areas indicating heart attack. Our hypothesis is that this new body mapping technique will be better than the standard electrocardiogram (ECG) in detecting heart attack.


Condition
Myocardial Infarction
Angina, Unstable
Myocardial Ischemia
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Comparison of Estimated Body Surface Potential Mapping With Standard Electrocardiography in Patients Presenting to the Emergency Department With Chest Pain

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 1320
Study Start Date: August 2001
Estimated Study Completion Date: December 2005
Detailed Description:

The overall aims of the proposed research are (1) to improve the ECG diagnosis of patients who present to the ER with heart attack and (2) to improve the monitoring of recurrent heart attack in these patients while they are being treated in the hospital. The proposed research will test a promising new technique, termed estimated body surface potential mapping. This novel method involves estimating ECG information across the entire upper body from 10 electrodes placed in strategic positions.

In patients who come to the ER complaining of chest pain, shortness of breath or some other symptom of a heart attack, we will: (1) record continuous, 24 hour, standard ECGs (usual, current method used) and at the same time (2)record continuous 24 hour experimental recordings from which a body surface map will be calculated. Two experts who do not know whether the patient actually had a heart attack or not will analyze these 2 methods for signs of heart attack. We expect that more correct diagnoses will happen with the new experimental body mapping technique. The correct diagnosis will be based upon a blood test which is considered the best test to prove there is heart damage. The blood test does not become abnormal until hours after the attack, however, so the ECG diagnosis must be made and treatment initiated before results of the blood test are available.

If the expected diagnostic improvements are confirmed in this study, the long term benefit would be more accurate ER decision-making of patients with heart attack and more timely treatment. The benefits of more timely and definitive treatment would be an improvement in long-term survival, functional status, and quality of life in patients treated for heart attack.

We plan to enroll 1,320 patients who present to the ER at the University of California, San Franicsco to participate in the study. We will follow these patients for a year following their ER visit to determine whether they survived and which ECG method predicted death more accurately.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All individuals who present to the UCSF emergency room between 7 am and 7 pm, Monday through Friday, who have symptoms of myocardial infarction.

Exclusion Criteria:

  • Patients with left bundle branch block or ventricular pacemaker rhythm
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00285922

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Barbara J Drew, PhD University of California, San Francisco
Study Director: Robert M Lux, PhD University of Utah, Salt Lake
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00285922     History of Changes
Other Study ID Numbers: RO1 HL69758-10
Study First Received: January 31, 2006
Last Updated: January 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
myocardial infarction
electrocardiography
myocardial ischemia
emergency medicine
monitoring, physiologic

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Angina, Unstable
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014