NCT00520559

Brief Summary

The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2\* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

First QC Date

August 23, 2007

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart Failure

    Ejection fraction

    1yr

  • Arrhythmia

    ECG

    1yr

Study Arms (1)

Thalassemia

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Please note that the age range detailed above refers to the normal group (63 patients): the study article provided by the study team to complete this record only provides a mean age range for the 39 Left Ventricular Dysfunction Group (50.1 +/- 14.0 years) and 24 Septal Infarction Group (58.6 +/- 13.9).

You may qualify if:

  • Thalassaemia Major
  • Patient must have had a cardiac MRI scan between 1999 and 2006

You may not qualify if:

  • Other structural heart disease such as valvular abnormalities, MI, congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kirk P, Roughton M, Porter JB, Walker JM, Tanner MA, Patel J, Wu D, Taylor J, Westwood MA, Anderson LJ, Pennell DJ. Cardiac T2* magnetic resonance for prediction of cardiac complications in thalassemia major. Circulation. 2009 Nov 17;120(20):1961-8. doi: 10.1161/CIRCULATIONAHA.109.874487. Epub 2009 Oct 2.

  • Kirk P, Sheppard M, Carpenter JP, Anderson L, He T, St Pierre T, Galanello R, Catani G, Wood J, Fucharoen S, Porter JB, Walker JM, Forni GL, Pennell DJ. Post-mortem study of the association between cardiac iron and fibrosis in transfusion dependent anaemia. J Cardiovasc Magn Reson. 2017 Mar 27;19(1):36. doi: 10.1186/s12968-017-0349-3.

  • Kirk P, He T, Anderson LJ, Roughton M, Tanner MA, Lam WW, Au WY, Chu WC, Chan G, Galanello R, Matta G, Fogel M, Cohen AR, Tan RS, Chen K, Ng I, Lai A, Fucharoen S, Laothamata J, Chuncharunee S, Jongjirasiri S, Firmin DN, Smith GC, Pennell DJ. International reproducibility of single breathhold T2* MR for cardiac and liver iron assessment among five thalassemia centers. J Magn Reson Imaging. 2010 Aug;32(2):315-9. doi: 10.1002/jmri.22245.

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dudley Pennell, MA, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

January 1, 2007

Study Completion

August 1, 2007

Last Updated

February 14, 2024

Record last verified: 2024-02