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Trial of Screening for ALOA-IgG AtheroAbzyme Test (OP512011)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272986
First Posted: January 10, 2011
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Omicron Pharmaceuticals
  Purpose
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.

Condition Intervention Phase
Myocardial Ischemia Acute Coronary Syndrome Device: ALOA IgG-Elisa Device: ALOA IgG-AtheroAbzyme Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients

Further study details as provided by Omicron Pharmaceuticals:

Primary Outcome Measures:
  • Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients [ Time Frame: Three months ]

Estimated Enrollment: 100
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy patients Device: ALOA IgG-Elisa
measurement of IgG Level in blood
Device: ALOA IgG-AtheroAbzyme
measurement of IgG in blood
Active Comparator: Asymptomatic myocardial Ischemic patients Device: ALOA IgG-Elisa
measurement of IgG Level in blood
Device: ALOA IgG-AtheroAbzyme
measurement of IgG in blood
Active Comparator: Acute Coronary Syndrome Patients Device: ALOA IgG-Elisa
measurement of IgG Level in blood
Device: ALOA IgG-AtheroAbzyme
measurement of IgG in blood

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272986


Locations
Lebanon
Bahman Hospital
Beirut, Haret Hriek, Lebanon
Sponsors and Collaborators
Omicron Pharmaceuticals
Investigators
Principal Investigator: Malek Mohamad Bahman Hospital
  More Information

Responsible Party: Hisham Ramadan, Omicron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01272986     History of Changes
Other Study ID Numbers: OP512011
First Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by Omicron Pharmaceuticals:
Determination of the level of oxidised LDL by measuring the level of IgG in Blood

Additional relevant MeSH terms:
Syndrome
Ischemia
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases