Back to resultsTrial of Screening for ALOA-IgG AtheroAbzyme Test (OP512011)
Primary Purpose
Myocardial Ischemia, Acute Coronary Syndrome
Status
Completed
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
ALOA IgG-Elisa
ALOA IgG-AtheroAbzyme
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Determination of the level of oxidised LDL by measuring the level of IgG in Blood
Eligibility Criteria
Inclusion Criteria:
- Healthy patients
- High Risk patients or Asymptomatic myocardial Ischemic patients
- Acute Coronary Syndrome patients
Exclusion Criteria:
- None
Sites / Locations
- Bahman Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Healthy patients
Asymptomatic myocardial Ischemic patients
Acute Coronary Syndrome Patients
Arm Description
Outcomes
Primary Outcome Measures
Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01272986
Brief Title
Trial of Screening for ALOA-IgG AtheroAbzyme Test
Acronym
OP512011
Official Title
Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Omicron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Acute Coronary Syndrome
Keywords
Determination of the level of oxidised LDL by measuring the level of IgG in Blood
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy patients
Arm Type
Placebo Comparator
Arm Title
Asymptomatic myocardial Ischemic patients
Arm Type
Active Comparator
Arm Title
Acute Coronary Syndrome Patients
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ALOA IgG-Elisa
Intervention Description
measurement of IgG Level in blood
Intervention Type
Device
Intervention Name(s)
ALOA IgG-AtheroAbzyme
Intervention Description
measurement of IgG in blood
Primary Outcome Measure Information:
Title
Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients
Time Frame
Three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy patients
High Risk patients or Asymptomatic myocardial Ischemic patients
Acute Coronary Syndrome patients
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malek Mohamad
Organizational Affiliation
Bahman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahman Hospital
City
Beirut
State/Province
Haret Hriek
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Trial of Screening for ALOA-IgG AtheroAbzyme Test
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