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

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:

MedlinePlus related topics: Chest Pain

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.


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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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


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:


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

ClinicalTrials.gov processed this record on September 28, 2016

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