Hemolytic AnemiaNCT07882303
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
An observational study of Hemolytic Anemia and Thalassemia, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Hemolytic Anemia, Thalassemia, Iron Overload
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 20 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 7 years or older with confirmed transfusion-dependent chronic hemolytic anemia referred for cardiac magnetic resonance at Assiut University Hospitals.
Who may be able to join
- - Confirmed transfusion-dependent chronic hemolytic anemia
- Age 7 years or older
- Able to cooperate with cardiac magnetic resonance without anesthesia
- Written informed consent
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Added Value of Native T1 Mapping and Extracellular Volume Calculation in the Detection of Myocardial Iron Overload and Fibrosis in Patients With Chronic Hemolytic Anemias
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.
- Conditions
- Hemolytic Anemia, Thalassemia, Iron Overload
- Keywords
- Extracellular volume, T2*, Myocardial, iron overload, Thalassemia, Assiut, Native T1 mapping
- Medical subject headings
- Anemia, Hemolytic, Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native T1 value
Mean global native T1 value in milliseconds measured by modified Look-Locker inversion recovery sequence.
Measured: Baseline
Secondary outcomes (4)
Extracellular volume fraction
Mean global extracellular volume fraction calculated from native and post-contrast T1 values corrected for hematocrit.
Measured: Baseline
T2* value
Mean mid-septal T2* value in milliseconds.
Measured: Baseline
Number of patients with myocardial iron overload
Number of patients with T2* less than 20 milliseconds.
Measured: Baseline
Number of patients with late gadolinium enhancement
Number of patients showing late gadolinium enhancement on post-contrast images.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Arafat Sadek, Assiut University
- Investigators
- Mostafa T Hussein, prof, Study chair, Diagnostic and interventional radiology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882303
- Sponsor's protocol ID
- CMR-T1-ECV-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Native T1 Mapping and Extracellular Volume Calculation in the Detection of Myocardial Iron Overload and Fibrosis in Patients With Chronic Hemolytic Anemias
- ClinicalTrials.gov ID
- NCT07882303
- Acronym / sponsor ID
- CMR-T1-ECV-Assiut-2026
- Conditions
- Hemolytic Anemia, Thalassemia, Iron Overload
- Keywords
- Extracellular volume, T2*, Myocardial, iron overload, Thalassemia, Assiut, Native T1 mapping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 7 years or older with confirmed transfusion-dependent chronic hemolytic anemia referred for cardiac magnetic resonance at Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - Confirmed transfusion-dependent chronic hemolytic anemia
- Age 7 years or older
- Able to cooperate with cardiac magnetic resonance without anesthesia
- Written informed consent
Key exclusion criteria (6 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Native T1 value
Time frame: Baseline
Mean global native T1 value in milliseconds measured by modified Look-Locker inversion recovery sequence.
4 secondary outcomes
Extracellular volume fraction
Time frame: Baseline
T2* value
Time frame: Baseline
Number of patients with myocardial iron overload
Time frame: Baseline
Number of patients with late gadolinium enhancement
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa T Hussein, prof study chair
Diagnostic and interventional radiology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic Anemia and Thalassemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamia A Sadek, Ass Lec (01064434489, lamia.arafat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Native T1 value (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.