NCT03177928

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

May 25, 2017

Last Update Submit

June 5, 2017

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

  • number of patients with cardiac complications in myeloproliferative diseases.

    cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension

    30 minutes

Study Arms (3)

study group

ACTIVE COMPARATOR

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

Device: Transthorathic echocardiogram

control group

ACTIVE COMPARATOR

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

control group 2

ACTIVE COMPARATOR

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

Interventions

Transthorathic echocardiogramDEVICE

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

control groupcontrol group 2study group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic criteria of myeloproliferative neoplasms.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 26299877BACKGROUND

  • 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.

    PMID: 27913526BACKGROUND

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

    PMID: 5183970BACKGROUND

  • 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.

    PMID: 24971434BACKGROUND

  • 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.

    PMID: 23768070BACKGROUND

  • 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.

    PMID: 27341755BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Osama A Ibrahim, Proffessor.

CONTACT

00201006372498oibrahiem@yahoo.com

Ahmed B Ahmed, lecturer.

CONTACT

00201009820300ahmadbahei@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 6, 2017

Study Start

September 1, 2017

Primary Completion

August 31, 2018

Study Completion

February 28, 2019

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share