Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797016
• Other study ID #: 0059-12-ZIV
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: November 13, 2014
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of platelet-leukocyte aggregates by routine blood count.		1 year	No