Novel Method to Diagnose Acute Myocardial Ischemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00285922|
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 2, 2006
|Condition or disease|
|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|
|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|
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|