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T-Wave Alternans in Patients With Suspected Acute Coronary Syndrome (TWA)

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ClinicalTrials.gov Identifier: NCT01137513
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to measure T-Wave Alternans (TWA) in patients with acute coronary syndrome. Researchers are blinded to clinical TWA measurements. The investigators will then try to determine if T-Wave alternans correlates with clinical outcome of patients with Acute Coronary Syndrome. During routine care of the patient, the T Wave Alternans is measured.

Condition or disease Intervention/treatment
Chest Pain Acute Coronary Syndrome Acute Myocardial Infarction Device: Observational Measurement of T-wave Alternans Device: T-wave Alternans

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Study Design
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Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: T-Wave Alternans in Patients Acute Coronary Syndrome
Study Start Date : July 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Chest Pain
Acute Myocardial ischemia
 Device: Observational Measurement of T-wave Alternans
Measurement is similar to typical EKG
Device: T-wave Alternans
T-Wave Alternans will be measured in an observational fashion


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. correlation of T-Wave Alternans with Acute myocardial Ischemia [ Time Frame: 6 month ]
    We hope to correlate the Twave Alternans with Acute Myocardial Ischemia. Most importantly we are trying to create a sensitive measure of acute myocardial Ischemia or a rule out study.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
18-100 Pt presenting with Chest Pain
Criteria

Inclusion Criteria:

  • Adults with Acute Chest Pain

Exclusion Criteria:

  • Patients with underlying myoclonic tremors making measurement artifact unreliable
  • Less than 18 years of age
  • Skin disorders that do not allow the Cardiac Monitor Leads to adhere to the skin
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01137513


Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92562
Sponsors and Collaborators
Loma Linda University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01137513     History of Changes
Other Study ID Numbers: RS-49780
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

Keywords provided by Loma Linda University:
Chest Pain
Acute coronary syndrome
AMI

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Disease
Pathologic Processes
Ischemia
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms