Myocardial IschemiaPhase 3OP512011NCT01272986
Trial of Screening for ALOA-IgG AtheroAbzyme Test
A Phase 3 study testing ALOA IgG-Elisa and ALOA IgG-AtheroAbzyme in people with Myocardial Ischemia and Acute Coronary Syndrome, run by Omicron Pharmaceuticals at 1 site in Lebanon.
Trial summary
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia, Acute Coronary Syndrome
- What is being tested?
- ALOA IgG-Elisa and ALOA IgG-AtheroAbzyme
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy patients
- High Risk patients or Asymptomatic myocardial Ischemic patients
- Acute Coronary Syndrome patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.
- Conditions
- Myocardial Ischemia, Acute Coronary Syndrome
- Being tested
- ALOA IgG-Elisa, ALOA IgG-AtheroAbzyme
- Keywords
- Determination of the level of oxidised LDL by measuring the level of IgG in Blood
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALOA IgG-ElisaDevice
measurement of IgG Level in blood
ALOA IgG-AtheroAbzymeDevice
measurement of IgG in blood
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Placebo comparator | Not described Receives: Device: ALOA IgG-Elisa; Device: ALOA IgG-AtheroAbzyme |
| Asymptomatic myocardial Ischemic patients | Active comparator | Not described Receives: Device: ALOA IgG-Elisa; Device: ALOA IgG-AtheroAbzyme |
| Acute Coronary Syndrome Patients | Active comparator | Not described Receives: Device: ALOA IgG-Elisa; Device: ALOA IgG-AtheroAbzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omicron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Malek Mohamad, Principal investigator, Bahman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272986
- Sponsor's protocol ID
- OP512011
- Acronym
- OP512011
- Status last verified
- Mar 2011
- First submitted
- 7 Jan 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT01272986
- Acronym / sponsor ID
- OP512011 / OP512011
- Conditions
- Myocardial Ischemia, Acute Coronary Syndrome
- Keywords
- Determination of the level of oxidised LDL by measuring the level of IgG in Blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Omicron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | Placebo comparator | Device: ALOA IgG-Elisa, Device: ALOA IgG-AtheroAbzyme |
| Asymptomatic myocardial Ischemic patients | Active comparator | Device: ALOA IgG-Elisa, Device: ALOA IgG-AtheroAbzyme |
| Acute Coronary Syndrome Patients | Active comparator | Device: ALOA IgG-Elisa, Device: ALOA IgG-AtheroAbzyme |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy patients
- High Risk patients or Asymptomatic myocardial Ischemic patients
- Acute Coronary Syndrome patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALOA IgG-Elisameasurement of IgG Level in blood | Device | Acute Coronary Syndrome Patients, Asymptomatic myocardial Ischemic patients, Healthy patients |
| ALOA IgG-AtheroAbzymemeasurement of IgG in blood | Device | Acute Coronary Syndrome Patients, Asymptomatic myocardial Ischemic patients, Healthy patients |
Primary outcome
Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malek Mohamad principal investigator
Bahman Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALOA IgG-Elisa and ALOA IgG-AtheroAbzyme in people with Myocardial Ischemia and Acute Coronary Syndrome, run by Omicron Pharmaceuticals at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.