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Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Najib Dally, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01797016
First received: February 19, 2013
Last updated: November 13, 2014
Last verified: November 2014

February 19, 2013
November 13, 2014
January 2013
September 2014   (final data collection date for primary outcome measure)
Detection of platelet-leukocyte aggregates by routine blood count. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01797016 on ClinicalTrials.gov Archive Site
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Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers
Comparing Blood Count Test Measures to Flow Cytometry in Healthy Patients to Acute General Syndrome Patients

This project aims to refine previous studies including the investigators work recently published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a relationship between the level of platelet leukocyte aggregates in patients with acute coronary syndrome. The investigators intend to compare the characteristics of platelets, monocytes and neutrophil data of volume, scatter and conductivity obtained from routine blood count level with flow cytometry results defining platelet leukocyte aggregates. The investigators hypothesize that there will be a direct correlation between elevated platelet-leukocyte aggregates and biophysical data from the blood count.

The goal is to investigate whether there is a simple and inexpensive method to test the level of platelet leukocyte aggregates through the blood count test. The parameters which are obtained routinely for white blood cell counts include: capacity - electrical conductivity (conductivity) - dispersion (scatter), and volume. Though these values are not reported routinely, they can be accessed for each blood count.

The premise is that through blood counts (no need for specialized flow cytometry) and through the parameters mentioned a conclusion can be reached about platelet leukocyte aggregates. This will then aid in prognosis about the risk of an acute event for every patient with ischemic heart disease who comes to the emergency room.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Acute Myocardial Infact

Myocardial Infarction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:Signed consent form, over 18 years of age, diagnosis of STEMI or non-STEMI as per following:

  • Acute ST Elevation Myocardial Infarction (STEMI) was diagnosed in patients with high level of troponin I (>0.4 ng/ml), ST segment elevation in at least two contiguous leads of the ECG (or new LBBB) and/or ischemic chest pain.
  • Acute Non ST Elevation Myocardial Infarction (Non STEMI) was diagnosed if level of troponin I was > 0.4 ng/ml, patient had ischemic chest pain or ST-T depression and/or T-wave inversion on ECG.

Exclusion Criteria:Inability to sign consent form, under 18, participation in other research projects within previous 6 months.

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Both
18 Years to 67 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01797016
0059-12-ZIV
No
Dr. Najib Dally, Ziv Hospital
Ziv Hospital
Not Provided
Principal Investigator: Nagib Dally, MD Ziv Medical Center
Ziv Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP