NCT01816399

Brief Summary

The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will facilitate the detection of significant coronary disease (CAD) in patients with normal rest 12-leads ECG (NE).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

March 20, 2013

Last Update Submit

March 21, 2013

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Detection of CAD in patients undergoing routine coronary angiography

    Following angiography patients will be categorized as having normal coronary arteries (NC) or coronary disease (CD) if more than 50% lumen diameter narrowing is found in one of the arteries.

    One month

Study Arms (1)

Routine coronary angiography patients

Procedure: Routine coronary angiography

Interventions

Routine coronary angiographyPROCEDURE
Routine coronary angiography patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing routine coronary angiography

You may qualify if:

  • Patients with normal rest 12-leads ECG

You may not qualify if:

  • Patients with significant irregular heart beat
  • Patients with heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Aharon Frimerman, MD

CONTACT

972-523-543264afrimer@gmail.com

Study Design

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

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

IL(1)