Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT01797016
• Lead Sponsor: Ziv Hospital

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-22
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of platelet-leukocyte aggregates by routine blood count.	1 year

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Safed, Israel