Myocardial InfarctionNCT00285922
Novel Method to Diagnose Acute Myocardial Ischemia
An observational study of Myocardial Infarction and Angina, Unstable, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Angina, Unstable, Myocardial Ischemia
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals who present to the UCSF emergency room between 7 am and 7 pm, Monday through Friday, who have symptoms of myocardial infarction.
Who cannot join
- Patients with left bundle branch block or ventricular pacemaker rhythm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Comparison of Estimated Body Surface Potential Mapping With Standard Electrocardiography in Patients Presenting to the Emergency Department With Chest Pain
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.
Read the 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.
- Keywords
- myocardial infarction, electrocardiography, myocardial ischemia, emergency medicine, monitoring, physiologic
- Medical subject headings
- Myocardial Infarction, Angina, Unstable, Myocardial Ischemia, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startAug 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,320 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Barbara J Drew, PhD, Principal investigator, University of California, San FranciscoRobert M Lux, PhD, Study director, University of Utah, Salt Lake
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285922
- Sponsor's protocol ID
- RO1 HL69758-10
- Status last verified
- Jul 2005
- First submitted
- 31 Jan 2006
- Last updated
- 2 Feb 2006
- Results posted
- No
Publications
Lux R, Bilbao M, Pelter M, Fleischmann K, Zegre J, Schindler D, Drew B. Optimal leads, estimation, and continuous monitoring improve detection of acute MI and transient ischemia. J Electrocardiol. 2004;37 Suppl:240-3. doi: 10.1016/j.jelectrocard.2004.08.064. No abstract available.
PubMed 15534848
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Estimated Body Surface Potential Mapping With Standard Electrocardiography in Patients Presenting to the Emergency Department With Chest Pain
- ClinicalTrials.gov ID
- NCT00285922
- Acronym / sponsor ID
- RO1 HL69758-10
- Keywords
- myocardial infarction, electrocardiography, myocardial ischemia, emergency medicine, monitoring, physiologic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,320 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Dec 2005
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals who present to the UCSF emergency room between 7 am and 7 pm, Monday through Friday, who have symptoms of myocardial infarction.
Key exclusion criteria (1 listed)
- Patients with left bundle branch block or ventricular pacemaker rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2006.
- Background: PubMed 15534848Lux R, Bilbao M, Pelter M, Fleischmann K, Zegre J, Schindler D, Drew B. Optimal leads, estimation, and continuous monitoring improve detection of acute MI and transient ischemia. J Electrocardiol. 2004;37 Suppl:240-3. doi: 10.1016/j.jelectrocard.2004.08.064. No abstract available.
- Faculty profileLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J Drew, PhD principal investigator
University of California, San Francisco
Robert M Lux, PhD study director
University of Utah, Salt Lake
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Angina, Unstable, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00285922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2006.