NCT01870258

Brief Summary

prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

May 24, 2013

Last Update Submit

June 4, 2013

Conditions

Myocardial InfarctionArtificial Neural Network

Keywords

Myocardial infarctionartificial neural networksElectrocardiography

Outcome Measures

Primary Outcomes (1)

  • myocardial infarction

    2 weeks

Secondary Outcomes (1)

  • hospital admission due to cardiac events

    2 weeks

Study Arms (2)

those without MI in 2 weeks

PLACEBO COMPARATOR

patient without MI in 2 weeks

Other: ANN prediction of myocardial infarction

patient with MI

ACTIVE COMPARATOR

group with MI in 2 weeks

Other: ANN prediction of myocardial infarction

Interventions

ANN prediction of myocardial infarctionOTHER
Also known as: sofware detected risk of new myocardial infraction
patient with MIthose without MI in 2 weeks

Eligibility Criteria

Age40 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with chest pain refered to ER with nondiagnostic ECG

You may not qualify if:

  • \) Absence of a history of myocardial infarction
  • \) Absence of bundle branch block, Wolf-Parkinson-White abnormality, ventricular hypertrophy or previous ECG signs of myocardial infarction,
  • \) Absence of a history of percutaneous coronary surgery or coronary artery bypass grafting,
  • \) Absence of ECG abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 6, 2013

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

June 6, 2013

Record last verified: 2013-06