Ischemic Mitral RegurgitationNCT04106648
Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
An observational study of Ischemic Mitral Regurgitation, run by Assiut University.
Trial summary
The goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Mitral Regurgitation
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 20 Sep 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with STEMI undergoing PPCI
Who may be able to join
- Subjects with first presentation
- Subjects with Acute STEMI
- Subjects undergoing Primary PCI with Successful reperfusion
- Subjects with significant IMR Grade (III/IV) to (IV/IV)
- Subjects with acute STEMI with no or non-significant MR undergoing Primary PCI undergoing primary PCI with successful reperfusion (as control)
Who cannot join
- Rheumatic mitral regurge
- Valvular mitral regurge
- IMR Grade (II/IV)
- Cardiomyopathies
- Associated other valvular heart diseases
Trial locations and contacts
No sites are listed yet.
About this study
The goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months
Read the detailed description
- IMR is defined as mitral regurgitation (MR) caused by chronic changes of LV structure and function due to ischemic heart disease. It is not a valve disease but represents the valvular consequences of increased tethering forces and reduced closing forces. It is reported in approximately one-fifth of patients following acute myocardial infarction (MI) and one-half of those with congestive heart failure. IMR is a frequent complication of coronary artery disease and it worsens the prognosis.
- It is important to distinguish between primary MR due to organic disease of one or more components of the mitral valve apparatus and secondary MR which is not a valve disease, but represents LV disease. Secondary MR is defined as functional MR, due to LV remodeling by cardiomyopathy or coronary artery disease. In the latter clinical setting, secondary functional MR is called IMR. There are some limitations in this definition of functional IMR. Recent studies have revealed evidence of structural changes in the mitral leaflets in response to tethering on them by LV pathological remodeling. The leaflet adaptation includes enlargement and increased stiffness.
- Aim of the work :
To correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months
- Conditions
- Ischemic Mitral Regurgitation
- Keywords
- Ischemic Mitral Regurgitation, primary percutaneous coronary intervention, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI
clinical data and echocardiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Nov 2020 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Mitral RegurgitationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Usama Amin Kostandy, Assiut University
- Investigators
- Fady Usama Kostandy, Msc, Principal investigator, Assiut UniversityHatem Abd El Rahman, Professor, Study director, Assiut UniversityMagdy Ibrahim Eldesowky, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106648
- Sponsor's protocol ID
- Ischemic mitral regurgitation
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04106648
- Acronym / sponsor ID
- Ischemic mitral regurgitation
- Conditions
- Ischemic Mitral Regurgitation
- Keywords
- Ischemic Mitral Regurgitation, primary percutaneous coronary intervention, STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 27 Sep 2019 (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.
The goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months
Detailed description
- IMR is defined as mitral regurgitation (MR) caused by chronic changes of LV structure and function due to ischemic heart disease. It is not a valve disease but represents the valvular consequences of increased tethering forces and reduced closing forces. It is reported in approximately one-fifth of patients following acute myocardial infarction (MI) and one-half of those with congestive heart failure. IMR is a frequent complication of coronary artery disease and it worsens the prognosis.
- It is important to distinguish between primary MR due to organic disease of one or more components of the mitral valve apparatus and secondary MR which is not a valve disease, but represents LV disease. Secondary MR is defined as functional MR, due to LV remodeling by cardiomyopathy or coronary artery disease. In the latter clinical setting, secondary functional MR is called IMR. There are some limitations in this definition of functional IMR. Recent studies have revealed evidence of structural changes in the mitral leaflets in response to tethering on them by LV pathological remodeling. The leaflet adaptation includes enlargement and increased stiffness.
- Aim of the work :
To correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with STEMI undergoing PPCI
Key inclusion criteria (5 listed)
- Subjects with first presentation
- Subjects with Acute STEMI
- Subjects undergoing Primary PCI with Successful reperfusion
- Subjects with significant IMR Grade (III/IV) to (IV/IV)
- Subjects with acute STEMI with no or non-significant MR undergoing Primary PCI undergoing primary PCI with successful reperfusion (as control)
Key exclusion criteria (5 listed)
- Rheumatic mitral regurge
- Valvular mitral regurge
- IMR Grade (II/IV)
- Cardiomyopathies
- Associated other valvular heart diseases
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
effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI
Time frame: 3 months
clinical data and echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Related trials for Ischemic Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke
Arterial Ischemic Stroke
Not yet recruitingObservational study
Impact of Stroke Unit Care on Acute Stroke Outcomes
Acute Stroke, Ischemic Stroke
Recruiting
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Cardiogenic Shock, Mitral Regurgitation
Active, not recruiting
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Mitral Regurgitation
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.
Fady Usama Kostandy, Msc principal investigator
Assiut University
Hatem Abd El Rahman, Professor study director
Assiut University
Magdy Ibrahim Eldesowky, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Mitral Regurgitation, 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 5 inclusion and 5 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 22 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fady Usama Kostandy, Msc (1277895809 ext. +20, f.usama.kostandy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI (time frame: 3 months). 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 22 Jan 2020.