Rheumatic Heart DiseaseNCT03156972
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge
A study testing Replacment of mitral valve in people with Rheumatic Heart Disease, run by Mohammed mahmoud mohammed othman at 1 site in Egypt.
Trial summary
Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper… Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Replacment of mitral valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- rhuematic heart disease with severe mitral regurge
Who cannot join
- non rheumatic mitral regurge
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut
Mohammed Mr Ahmed atef, 01208083083 ext. 002
About this study
Official title: Assessment of Rheumatic Heart Disease Patients With Chronic Severe Mitral Regurge by Speckle Tracking Echocardiography for Proper Timing of Surgical Operation.
Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery
- Conditions
- Rheumatic Heart Disease
- Being tested
- Replacment of mitral valve
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replacment of mitral valveProcedure or surgery
Mitral valve replacment by prothsis
| Study group | Role | What they receive |
|---|---|---|
| Group a | Active comparator | Not described Receives: Procedure: Replacment of mitral valve |
| Group b | Active comparator | Not described Receives: Procedure: Replacment of mitral valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of surgical operation in patients with chronic severe mitral regurge
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed mahmoud mohammed othman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed mahmoud mohammed othman, Assiut University
- Investigators
- Mohammed Aly, Prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156972
- Sponsor's protocol ID
- Ossman231speckle
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Rheumatic Heart Disease Patients With Chronic Severe Mitral Regurge by Speckle Tracking Echocardiography for Proper Timing of Surgical Operation.
- ClinicalTrials.gov ID
- NCT03156972
- Acronym / sponsor ID
- Ossman231speckle
- Conditions
- Rheumatic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohammed mahmoud mohammed othmanUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 17 May 2017 (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.
Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group a | Active comparator | Procedure: Replacment of mitral valve |
| Group b | Active comparator | Procedure: Replacment of mitral valve |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- rhuematic heart disease with severe mitral regurge
Key exclusion criteria (1 listed)
- non rheumatic mitral regurge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replacment of mitral valveMitral valve replacment by prothsis | Procedure or surgery | Group a, Group b |
Primary outcome
Timing of surgical operation in patients with chronic severe mitral regurge
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- 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. This study is not recruiting at the moment.
Mohammed Aly, Prof principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replacment of mitral valve in people with Rheumatic Heart Disease, run by Mohammed mahmoud mohammed othman at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Dr Othman, Master (01002748383 ext. 002, Ossman231@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of surgical operation in patients with chronic severe mitral regurge (time frame: One year). 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 17 May 2017.