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

This study is currently recruiting participants.
Verified June 2011 by Loma Linda University
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01137513
First received: June 3, 2010
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Chest Pain
Acute Coronary Syndrome
Acute Myocardial Infarction
 Device: Observational Measurement of T-wave Alternans
Device: T-wave Alternans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: T-Wave Alternans in Patients Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • correlation of T-Wave Alternans with Acute myocardial Ischemia [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137513

Contacts
Contact: Robert Steele, MD 9095587171 rosteele@llu.edu
Contact: Ellen Reibling, PhD 909 558 7407 ereibling@llu.edu

Locations
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92562
Contact: Robert Steele, MD     909-558-7171     rosteele@llu.edu    
Contact: Ellen Reibling, PhD     909 558 7407     ereibling@llu.edu    
Sub-Investigator: Timothy McNaughton, MD            
Sponsors and Collaborators
Loma Linda University
  More Information

No publications provided

Responsible Party: Robert Steele, Loma Linda University
ClinicalTrials.gov Identifier: NCT01137513     History of Changes
Other Study ID Numbers: RS-49780
Study First Received: June 3, 2010
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Chest Pain
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Pain
Signs and Symptoms
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris

ClinicalTrials.gov processed this record on May 16, 2013