Cardiac Changes in Myeloproliferative Neoplasms

June 5, 2017 updated by: AKAli, Assiut University

Functional and Morphological Cardiac Changes in Myeloproliferative Neoplasms

Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or myeloid lineages and relatively normal maturation resulting in increased numbers of red cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase activation appears to be a common pathogenetic mechanism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to worldwide study of prevalence of myeloproliferative neoplasms revealed:

Incidence of polycythemia vera ranged 0.01 to 2.61 per 100.000 population and the prevalence ranging from 0.49 to 46.88 per 100.000 population. Incidence of essential thrombocythemia is 0.21 to 2.27 per 100.000 population, prevalence ranging between 11.00 - 42.51 per 100.000 population.

Primary myelofibrosis incidence is 1.15 -4.99 per 100.000 population and prevalence ranging between 1.76 - 4.05 per 100.000 population.In previous studies, cardiac involvement including coronary arterial thrombosis, myocardial infarction, pulmonary hypertension, asymptomatic pericardial effusion, cardiac tamponade, intractable cardiac failure due to intraventricular stenosis and valvular stenosis that occur in myeloproliferative neoplasms. There is a few number of studies in which cardiac lesions were evaluated in myeloproliferative neoplasms by using transthoracic echocardiography but still inadequate, so we need to understand more about cardiovascular complications in myeloproliferative neoplasms.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic criteria of myeloproliferative neoplasms.

Exclusion Criteria:

  • Extreme body weight e.g., morbid obesity.
  • Cardiac disease.
  • Cerebrovascular disorders.
  • Diabetes mellitus.
  • Dyslipidemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: study group
patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.
Device: Transthorathic echocardiogram
In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.
ACTIVE_COMPARATOR: control group
patients with hematological disorders including myeloproliferative neoplasms without cardiac affection by using echocardiogram. Intervention will be in the form of using transthorath echocardiography with all patients to reveal any cardiac abnormalities.
Device: Transthorathic echocardiogram
In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.
ACTIVE_COMPARATOR: control group 2
healthy people from the same age and sex will be investigated using echocardiogram. Intervention will be in the form of using transthorathic echocardiography.
Device: Transthorathic echocardiogram
In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with cardiac complications in myeloproliferative diseases.
Time Frame: 30 minutes
cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

August 31, 2018

Study Completion (ANTICIPATED)

February 28, 2019

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (ACTUAL)

June 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMPNS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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