NCT01137513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

June 3, 2010

Last Update Submit

May 22, 2014

Conditions

Chest PainAcute Coronary SyndromeAcute Myocardial Infarction

Keywords

Chest PainAcute coronary syndromeAMI

Outcome Measures

Primary Outcomes (1)

  • correlation of T-Wave Alternans with Acute myocardial Ischemia

    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.

    6 month

Study Arms (1)

Chest Pain

Acute Myocardial ischemia

Device: Observational Measurement of T-wave AlternansDevice: T-wave Alternans

Interventions

Observational Measurement of T-wave AlternansDEVICE

Measurement is similar to typical EKG

Chest Pain
T-wave AlternansDEVICE

T-Wave Alternans will be measured in an observational fashion

Chest Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-100 Pt presenting with Chest Pain

You may qualify if:

  • Adults with Acute Chest Pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92562, United States

Location

MeSH Terms

Conditions

Chest PainAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)