Comparison of Automated Blood Counts With Flow Cytometry Results in Healthy Adults vs Acute Myocardial Infarction Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Najib Dally, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01797016
First received: February 19, 2013
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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
Myocardial Infarction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Detection of platelet-leukocyte aggregates by routine blood count. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797016

Contacts
Contact: Najib Dally, MD +972-4-682-8580 nagib.d@ziv.health.gov.il
Contact: Elizabeth Eshel, BA +972-4-682-8151 batya.e@ziv.health.gov.il

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

No publications provided

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
Study First Received: February 19, 2013
Last Updated: July 17, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on August 27, 2014