Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01137513
First received: June 3, 2010
Last updated: May 22, 2014
Last verified: May 2014
  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:


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.


Enrollment: 252
Study Start Date: July 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137513

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92562
Sponsors and Collaborators
Loma Linda University
  More Information

No publications provided

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01137513     History of Changes
Other Study ID Numbers: RS-49780
Study First Received: June 3, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 19, 2014