Cardiac Changes in Myeloproliferative Neoplasms

NCT ID: NCT03177928

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myeloproliferative Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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study group

patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.

Group Type ACTIVE_COMPARATOR

Transthorathic echocardiogram

Intervention Type DEVICE

In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

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.

Group Type ACTIVE_COMPARATOR

Transthorathic echocardiogram

Intervention Type DEVICE

In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

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.

Group Type ACTIVE_COMPARATOR

Transthorathic echocardiogram

Intervention Type DEVICE

In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

Interventions

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Transthorathic echocardiogram

In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnostic criteria of myeloproliferative neoplasms.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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AKAli

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Osama A Ibrahim, Proffessor.

Role: CONTACT

00201006372498

Ahmed B Ahmed, lecturer.

Role: CONTACT

00201009820300

References

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How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2015 Sep;90(9):850. doi: 10.1002/ajh.23984. Epub 2015 Mar 30. No abstract available.

Reference Type BACKGROUND
PMID: 26299877 (View on PubMed)

Passamonti F, Maffioli M. Update from the latest WHO classification of MPNs: a user's manual. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):534-542. doi: 10.1182/asheducation-2016.1.534.

Reference Type BACKGROUND
PMID: 27913526 (View on PubMed)

Campbell A. Now I know why. Front Nurs Serv Q Bull. 1968 Winter;43(3):7-9. No abstract available.

Reference Type BACKGROUND
PMID: 5183970 (View on PubMed)

Titmarsh GJ, Duncombe AS, McMullin MF, O'Rorke M, Mesa R, De Vocht F, Horan S, Fritschi L, Clarke M, Anderson LA. How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2014 Jun;89(6):581-7. doi: 10.1002/ajh.23690.

Reference Type BACKGROUND
PMID: 24971434 (View on PubMed)

Mehta J, Wang H, Iqbal SU, Mesa R. Epidemiology of myeloproliferative neoplasms in the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600. doi: 10.3109/10428194.2013.813500. Epub 2013 Jul 29.

Reference Type BACKGROUND
PMID: 23768070 (View on PubMed)

Barbui T, Thiele J, Gisslinger H, Finazzi G, Vannucchi AM, Tefferi A. The 2016 revision of WHO classification of myeloproliferative neoplasms: Clinical and molecular advances. Blood Rev. 2016 Nov;30(6):453-459. doi: 10.1016/j.blre.2016.06.001. Epub 2016 Jun 11.

Reference Type BACKGROUND
PMID: 27341755 (View on PubMed)

Other Identifiers

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CCMPNS

Identifier Type: -

Identifier Source: org_study_id

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