Acute Chest SyndromeNCT01041339
ST Elevation in Acute Chest Pain; Could Measurement of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) be Helpful to the Clinician?
An observational study of Acute Chest Syndrome, run by Alexhander Izhaki at 1 site in Israel.
Trial summary
A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs mimicking infarction. A test of clinical potential if proven to be able to support either origin of acute chest pain etiology. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Chest Syndrome
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jan 2012
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: acute chest pain patients admitted to ICCU with acute ST elevation and elevated troponin
Who may be able to join
- acute chest pain
- acute ST elevation
- elevated troponin I
Who cannot join
- patients with recent (> 24 hour chest pain) myocardial infarction
- refusing to provide blood samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ST Elevation (Acute Coronary Syndrome Versus Pericarditis;Could Measurement of Lp-associated PLA2 -a Vascular Specific Marker of Inflammation- be Helpful to the Clinician?
A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs mimicking infarction. A test of clinical potential if proven to be able to support either origin of acute chest pain etiology.
Read the detailed description
Too many times young patients presenting with acute chest pain are referred to invasive angiography or treated with anticoagulation therapy a measure of detrimental effect in those inflicted with acute pericarditis.
A simple blood test (the PLAC test) may have some value in aiding rapid diagnosis saving need for cath.
- Conditions
- Acute Chest Syndrome
- Keywords
- LpPLA2, ST elevation, acute pericarditis
- Medical subject headings
- Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute chest pain ST elevation | patients admitted with acute chest pain sharing ST elevation in ER-ECG and elevated troponin | |
| controls | asymptomatic patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexhander Izhaki
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Alexhander Izhaki, Wolfson Medical Center
- Investigators
- Alexander J Izhaki, MD, Principal investigator, The E.Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041339
- Sponsor's protocol ID
- 0075-09-WOMC
- Status last verified
- Jun 2011
- First submitted
- 30 Dec 2009
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST Elevation (Acute Coronary Syndrome Versus Pericarditis;Could Measurement of Lp-associated PLA2 -a Vascular Specific Marker of Inflammation- be Helpful to the Clinician?
- ClinicalTrials.gov ID
- NCT01041339
- Acronym / sponsor ID
- 0075-09-WOMC
- Conditions
- Acute Chest Syndrome
- Keywords
- LpPLA2, ST elevation, acute pericarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexhander IzhakiOther government
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Dec 2009 (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.
A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs mimicking infarction. A test of clinical potential if proven to be able to support either origin of acute chest pain etiology.
Detailed description
Too many times young patients presenting with acute chest pain are referred to invasive angiography or treated with anticoagulation therapy a measure of detrimental effect in those inflicted with acute pericarditis.
A simple blood test (the PLAC test) may have some value in aiding rapid diagnosis saving need for cath.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute chest pain ST elevation | – | –patients admitted with acute chest pain sharing ST elevation in ER-ECG and elevated troponin |
| controls | – | –asymptomatic patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- acute chest pain patients admitted to ICCU with acute ST elevation and elevated troponin
Key inclusion criteria (3 listed)
- acute chest pain
- acute ST elevation
- elevated troponin I
Key exclusion criteria (2 listed)
- patients with recent (> 24 hour chest pain) myocardial infarction
- refusing to provide blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Dec 2015.
- Mayo Clin Proc. 2009;84(1):11-5.Link provided by the sponsor.
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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.
Alexander J Izhaki, MD principal investigator
The E.Wolfson MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Chest Syndrome, run by Alexhander Izhaki at 1 site in Israel.
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 2 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 15 Dec 2015. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 15 Dec 2015.