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Not yet recruitingNCT07882303Updated Oct 20, 2026

Native T1 Mapping and ECV in Chronic Hemolytic Anemia

An observational study in Hemolytic Anemia, Thalassemia and Iron Overload, sponsored by Assiut University. Not yet recruiting. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Assiut University · Observational

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
54
Ages
7 Years and older
Sex
All
01

Study summary

This cross-sectional study aims to evaluate the diagnostic performance of native T1 mapping and extracellular volume fraction for the detection of myocardial iron overload and fibrosis in patients with chronic hemolytic anemia compared with T2* relaxometry.

Read the detailed description

Patients with transfusion-dependent chronic hemolytic anemia are at risk of myocardial iron overload and fibrosis. Cardiovascular magnetic resonance T2* is the reference method for iron quantification, but native T1 mapping and extracellular volume may provide complementary information.

This observational study will perform cardiac magnetic resonance including native T1 mapping, T2*, post-contrast T1 for extracellular volume calculation, and late gadolinium enhancement in patients aged 7 years or older with chronic hemolytic anemia.

02

Conditions studied

  • Hemolytic Anemia
  • Thalassemia
  • Iron Overload

Keywords

  • Extracellular volume
  • T2*
  • Myocardial
  • iron overload
  • Thalassemia
  • Assiut
  • Native T1 mapping
03

In context

Anemia, Hemolytic

87 studies on the registry are indexed under Anemia, Hemolytic; 26 are open to participants now.

This study's planned enrollment of 54 is below the median of 105 across 24 observational studies indexed under Anemia, Hemolytic.

Browse Anemia, Hemolytic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 7 years or older with confirmed transfusion-dependent chronic hemolytic anemia referred for cardiac magnetic resonance at Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Confirmed transfusion-dependent chronic hemolytic anemia
  • Age 7 years or older
  • Able to cooperate with cardiac magnetic resonance without anesthesia
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • - MRI contraindication
  • Non-diagnostic cardiac magnetic resonance
  • Unrelated cardiovascular disease or prior cardiac surgery
  • Non-transfusional cause of cardiac iron overload
  • Gadolinium contraindication (native sequences still performed)
  • Refusal of informed consent
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
54 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with Chronic Hemolytic Anemia

    Patients with transfusion-dependent chronic hemolytic anemia undergoing cardiac magnetic resonance with native T1 mapping, T2\*, and extracellular volume assessment.

06

What researchers measure

Primary outcomes

  1. Native T1 value

    Mean global native T1 value in milliseconds measured by modified Look-Locker inversion recovery sequence.

    Time frame: Baseline

Secondary outcomes

  1. Extracellular volume fraction

    Mean global extracellular volume fraction calculated from native and post-contrast T1 values corrected for hematocrit.

    Time frame: Baseline

  2. T2* value

    Mean mid-septal T2\* value in milliseconds.

    Time frame: Baseline

  3. Number of patients with myocardial iron overload

    Number of patients with T2\* less than 20 milliseconds.

    Time frame: Baseline

  4. Number of patients with late gadolinium enhancement

    Number of patients showing late gadolinium enhancement on post-contrast images.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882303
Lead sponsor
Assiut University
Responsible party
Lamiaa Arafat Sadek (Assistant Lecturer of Diagnostic and Interventional Radiology, Assiut University) — Principal investigator
First posted
Oct 20, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Oct 20, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Lamia A Sadek, Ass Lec
Contact
lamia.arafat@yahoo.com
01064434489
Mostafa T Hussein, prof
study chair · Diagnostic and interventional radiology Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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