Novel Method to Diagnose Acute Myocardial Ischemia
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ClinicalTrials.gov Identifier: NCT00285922 |
Recruitment Status :
Completed
First Posted : February 2, 2006
Last Update Posted : February 2, 2006
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Condition or disease |
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Myocardial Infarction Angina, Unstable Myocardial Ischemia Coronary Disease |
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.
Study Type : | Observational |
Enrollment : | 1320 participants |
Observational Model: | Defined Population |
Time Perspective: | Prospective |
Official Title: | Comparison of Estimated Body Surface Potential Mapping With Standard Electrocardiography in Patients Presenting to the Emergency Department With Chest Pain |
Study Start Date : | August 2001 |
Study Completion Date : | December 2005 |

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285922
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Barbara J Drew, PhD | University of California, San Francisco | |
Study Director: | Robert M Lux, PhD | University of Utah, Salt Lake |
Publications:
ClinicalTrials.gov Identifier: | NCT00285922 |
Other Study ID Numbers: |
RO1 HL69758-10 |
First Posted: | February 2, 2006 Key Record Dates |
Last Update Posted: | February 2, 2006 |
Last Verified: | July 2005 |
myocardial infarction electrocardiography myocardial ischemia emergency medicine monitoring, physiologic |
Myocardial Infarction Coronary Disease Coronary Artery Disease Myocardial Ischemia Angina, Unstable Infarction Ischemia Pathologic Processes Necrosis |
Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Angina Pectoris Chest Pain Pain Neurologic Manifestations |