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Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01797016
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Myocardial Infarction

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparing Blood Count Test Measures to Flow Cytometry in Healthy Patients to Acute General Syndrome Patients
Study Start Date : January 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Detection of platelet-leukocyte aggregates by routine blood count. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Acute Myocardial Infact
Criteria

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.

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): NCT01797016


Locations
Israel
Ziv Medical Center
Safed, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Nagib Dally, MD Ziv Medical Center
More Information

Responsible Party: Dr. Najib Dally, Head of Hematology Institute, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01797016     History of Changes
Other Study ID Numbers: 0059-12-ZIV
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Dr. Najib Dally, Ziv Hospital:
Myocardial Infarction
flow cytometry
Blood Cell Count
Platelet Activation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases