NCT01272986

Brief Summary

This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

2 months

First QC Date

January 7, 2011

Last Update Submit

March 6, 2011

Conditions

Myocardial IschemiaAcute Coronary Syndrome

Keywords

Determination of the level of oxidised LDL by measuring the level of IgG in Blood

Outcome Measures

Primary Outcomes (1)

  • Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients

    Three months

Study Arms (3)

Healthy patients

PLACEBO COMPARATOR
Device: ALOA IgG-ElisaDevice: ALOA IgG-AtheroAbzyme

Asymptomatic myocardial Ischemic patients

ACTIVE COMPARATOR
Device: ALOA IgG-ElisaDevice: ALOA IgG-AtheroAbzyme

Acute Coronary Syndrome Patients

ACTIVE COMPARATOR
Device: ALOA IgG-ElisaDevice: ALOA IgG-AtheroAbzyme

Interventions

ALOA IgG-ElisaDEVICE

measurement of IgG Level in blood

Acute Coronary Syndrome PatientsAsymptomatic myocardial Ischemic patientsHealthy patients
ALOA IgG-AtheroAbzymeDEVICE

measurement of IgG in blood

Acute Coronary Syndrome PatientsAsymptomatic myocardial Ischemic patientsHealthy patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy patients
  • High Risk patients or Asymptomatic myocardial Ischemic patients
  • Acute Coronary Syndrome patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahman Hospital

Beirut, Haret Hriek, Lebanon

Location

MeSH Terms

Conditions

Myocardial IschemiaAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Malek Mohamad

    Bahman Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

LE(1)