Mitral RegurgitationNCT06707506
Atrial Fibrillation Risk After Miniinvasive Mitral Valve Repair
An observational study of Mitral Regurgitation and Computed Tomography, run by Nemocnice AGEL Trinec-Podlesi a.s..
Trial summary
This retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve surgery. Read more about this study
- Who is it for?
- Ages 19 to 110 years
- Conditions the study is for
- Mitral Regurgitation, Computed Tomography, Atrial Fibrillation
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Aug 2024
- 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 19 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This single-center retrospective cohort study included 114 consecutive patients who underwent minimally invasive mitral valve surgery between January 2014 and November 2023 at the Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi.
Who may be able to join
- Age ≥ 18 years
- Undergoing minimally invasive mitral valve surgery
- Preoperative CT scan available
- Surgery between January 2014 and November 2023
Who cannot join
- Incomplete clinical data
- Poor quality CT images
- Previous cardiac surgery
About this study
Official title: CT-Derived Metabolic Parameters as Predictors of Post-Operative Atrial Fibrillation Following Minimally Invasive Mitral Valve Surgery: The MiniMitral AF Study
This retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve surgery. The study leverages established associations between adipose tissue characteristics and metabolic dysfunction to explore their potential role in post-surgical arrhythmogenesis.
Read the detailed description
Scientific Background and Rationale Post-operative atrial fibrillation (POAF) affects up to 30% of patients following cardiac surgery and significantly impacts outcomes. While traditional risk factors are well-documented, the role of underlying metabolic dysfunction in arrhythmogenesis remains poorly understood. Recent evidence suggests that tissue-specific metabolic alterations, particularly in adipose tissue distribution and quality, may provide crucial insights into arrhythmic risk. CT-derived tissue quality parameters (measured in Hounsfield Units) have been validated as markers of metabolic status, with studies demonstrating associations between adipose tissue density and inflammatory states. This study aims to investigate whether these metabolic markers can predict POAF risk in the specific context of mitral valve surgery, potentially informing risk stratification and preventive strategies.
Primary Objective To determine whether CT-derived tissue quality parameters (adipose tissue density, muscle density) independently predict post-operative atrial fibrillation risk following minimally invasive mitral valve surgery.
Study Design
Observational Model: Retrospective Cohort Setting: Single-center study at Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi Time Frame: January 2014 - November 2023 Follow-up: Through August 1, 2024
Primary Outcome Measure Post-operative Atrial Fibrillation [Time Frame: Up to 30 days post-surgery]
Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history
Secondary Outcome Measures
Overall Survival [Through August 1, 2024]
Perioperative Complications:
Blood product utilization Duration of mechanical ventilation ICU length of stay Total hospital length of stay
Key Study Groups
AF-Naïve Group (n=56):
No previous AF history Primary prevention cohort
AF-History Group (n=48):
Preexisting AF with concurrent Maze procedure Secondary prevention cohort
CT Analysis Methods
Automated segmentation at L3 vertebral level
Parameters measured:
Muscle density (HU) Intramuscular adipose tissue density (IMAT HU) Visceral adipose tissue density (VAT HU) Subcutaneous adipose tissue density (SAT HU) Skeletal muscle index (SMI)
Statistical Analysis Plan
Primary analysis: Logistic regression for POAF prediction Interaction analysis between tissue parameters and AF history Adjustment for age, gender, and traditional risk factors Separate models for AF-naïve and AF-history groups
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years Undergoing minimally invasive mitral valve surgery Preoperative CT scan available Surgery between January 2014 and November 2023
Exclusion Criteria:
Incomplete clinical data Poor quality CT images Previous cardiac surgery
Sample Size 114 total participants (104 included in primary analysis) Study Status
Completed enrollment Final follow-up: August 1, 2024 Ethics Committee Approval: EK 65/24
Principal Investigators
Matej Pekar, MD David Vician, MD Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi
Funding Sources
MUNI/A/1547/2023 MUNI/A/1555/2023 Ministry of Education, Youth, and Sports of the Czech Republic
- Keywords
- Post-operative Atrial Fibrillation, Body Composition, Computed Tomography, Mitral Valve Surgery, Metabolic Risk Factors
- Medical subject headings
- Mitral Valve Insufficiency, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative atrial fibrillation development
Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history
Measured: Through August 1, 2024
Secondary outcomes (2)
Overall Survival
Overall Survival in the cohort
Measured: Through August 1, 2024
Perioperative Complications
Blood product utilization Duration of mechanical ventilation ICU length of stay Total hospital length of stay
Measured: Through August 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2014
- Primary completion30 Nov 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707506
- Sponsor's protocol ID
- EK 65/24
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Derived Metabolic Parameters as Predictors of Post-Operative Atrial Fibrillation Following Minimally Invasive Mitral Valve Surgery: The MiniMitral AF Study
- ClinicalTrials.gov ID
- NCT06707506
- Acronym / sponsor ID
- EK 65/24
- Keywords
- Post-operative Atrial Fibrillation, Body Composition, Computed Tomography, Mitral Valve Surgery, Metabolic Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 Nov 2024 (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 retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve surgery. The study leverages established associations between adipose tissue characteristics and metabolic dysfunction to explore their potential role in post-surgical arrhythmogenesis.
Detailed description
Scientific Background and Rationale Post-operative atrial fibrillation (POAF) affects up to 30% of patients following cardiac surgery and significantly impacts outcomes. While traditional risk factors are well-documented, the role of underlying metabolic dysfunction in arrhythmogenesis remains poorly understood. Recent evidence suggests that tissue-specific metabolic alterations, particularly in adipose tissue distribution and quality, may provide crucial insights into arrhythmic risk. CT-derived tissue quality parameters (measured in Hounsfield Units) have been validated as markers of metabolic status, with studies demonstrating associations between adipose tissue density and inflammatory states. This study aims to investigate whether these metabolic markers can predict POAF risk in the specific context of mitral valve surgery, potentially informing risk stratification and preventive strategies.
Primary Objective To determine whether CT-derived tissue quality parameters (adipose tissue density, muscle density) independently predict post-operative atrial fibrillation risk following minimally invasive mitral valve surgery.
Study Design
Observational Model: Retrospective Cohort Setting: Single-center study at Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi Time Frame: January 2014 - November 2023 Follow-up: Through August 1, 2024
Primary Outcome Measure Post-operative Atrial Fibrillation [Time Frame: Up to 30 days post-surgery]
Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history
Secondary Outcome Measures
Overall Survival [Through August 1, 2024]
Perioperative Complications:
Blood product utilization Duration of mechanical ventilation ICU length of stay Total hospital length of stay
Key Study Groups
AF-Naïve Group (n=56):
No previous AF history Primary prevention cohort
AF-History Group (n=48):
Preexisting AF with concurrent Maze procedure Secondary prevention cohort
CT Analysis Methods
Automated segmentation at L3 vertebral level
Parameters measured:
Muscle density (HU) Intramuscular adipose tissue density (IMAT HU) Visceral adipose tissue density (VAT HU) Subcutaneous adipose tissue density (SAT HU) Skeletal muscle index (SMI)
Statistical Analysis Plan
Primary analysis: Logistic regression for POAF prediction Interaction analysis between tissue parameters and AF history Adjustment for age, gender, and traditional risk factors Separate models for AF-naïve and AF-history groups
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years Undergoing minimally invasive mitral valve surgery Preoperative CT scan available Surgery between January 2014 and November 2023
Exclusion Criteria:
Incomplete clinical data Poor quality CT images Previous cardiac surgery
Sample Size 114 total participants (104 included in primary analysis) Study Status
Completed enrollment Final follow-up: August 1, 2024 Ethics Committee Approval: EK 65/24
Principal Investigators
Matej Pekar, MD David Vician, MD Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi
Funding Sources
MUNI/A/1547/2023 MUNI/A/1555/2023 Ministry of Education, Youth, and Sports of the Czech Republic
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center retrospective cohort study included 114 consecutive patients who underwent minimally invasive mitral valve surgery between January 2014 and November 2023 at the Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Undergoing minimally invasive mitral valve surgery
- Preoperative CT scan available
- Surgery between January 2014 and November 2023
Key exclusion criteria (3 listed)
- Incomplete clinical data
- Poor quality CT images
- Previous cardiac surgery
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
postoperative atrial fibrillation development
Time frame: Through August 1, 2024
Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history
2 secondary outcomes
Overall Survival
Time frame: Through August 1, 2024
Perioperative Complications
Time frame: Through August 1, 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Computed Tomography, run by Nemocnice AGEL Trinec-Podlesi a.s..
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 3 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: finished, as of the sponsor's last update on 27 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative atrial fibrillation development (time frame: Through August 1, 2024). 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 27 Nov 2024.