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

This study has been completed.
Sponsor:
Information provided by:
Omicron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01272986
First received: January 7, 2011
Last updated: March 6, 2011
Last verified: March 2011
History of Changes
  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: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272986

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

No publications provided

Responsible Party: Hisham Ramadan, Omicron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01272986     History of Changes
Other Study ID Numbers: OP512011
Study First Received: January 7, 2011
Last Updated: March 6, 2011
Health Authority: Lebanon: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
 Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013