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Completed

NCT Number: NCT01797016

Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

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.

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Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziv Medical Center

Safed, 13100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Detection of platelet-leukocyte aggregates by routine blood count.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Registry information

Official study title

Comparing Blood Count Test Measures to Flow Cytometry in Healthy Patients to Acute General Syndrome Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2013
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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