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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL133667-01A1 | U.S. NIH Grant/Contract | View source |
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The study was terminated due to poor enrollment during COVID-19, which also hindered postoperative testing. With insufficient enrollment to meet trial goals, funds were redirected to animal studies on the same clinical issues.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months.
A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.
Functional mitral regurgitation (FMR) is a common heart valve lesion that is observed in patients suffering for cardiomyopathies. Timely surgical repair of FMR can reduce volume overload and potentially improve cardiac function. Durable surgical techniques for FMR repair are lacking. Undersizing mitral annuloplasty (UMA) is the current technique of choice, but its durability is quite poor. Thirty five percent of the repairs fail within one year and 58% fail within 2 years.
One of the probable mechanisms causing UMA failure is elevated lateral inter-papillary muscle separation (IPMS). The study investigators are interested in understanding if the extent of lateral IPMS has a direct impact on the failure rates of UMA at 1 year post surgery. Secondly, the investigators are interested in determining if patients with elevated lateral IPMS benefit from papillary muscle approximation (PMA) along with UMA.
The investigators are interested in determining the best way to correct functional mitral regurgitation, as there is currently not one technique that is established to better than the other. The most common repair technique is called undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Another more recent technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. In this research study, the study team is investigating whether they can identify those patients who will benefit from one repair over another.
The primary objective of this protocol is to investigate if pre-operative IPMS is predictive of FMR severity at 12 months after UMA to repair FMR. Furthermore, whether a cut-off value of pre-operative inter-papillary muscle separation can be established to predict patients who might have failure of UMA.
The secondary objective of this protocol is to investigate if adding PMA to UMA is an effective technique in reducing recurrence of FMR at 12 months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UMA (Group 1) | Other | Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA). |
|
| UMA + PMA (Group 2) | Other | Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA). |
|
| Retrospectively identified patients | No Intervention | Retrospectively identified patients, who already underwent the standard of care surgery for the lesion of interest at Emory, within 6 months (± 1 month) after the date of their surgery, and are suitable for recruitment to the study for their post-operative research. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Undersizing Mitral Annuloplasty | Procedure | Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FMR Severity | The Severity (grade 0 to 4+) of mitral regurgitation of mitral regurgitation is measured using cardiac echocardiography and/or MRI (per physician's discretion). Grade 0: None Grade 1 (Mild): Small, restricted jet of regurgitation with minimal impact on the heart's function. Typically, no symptoms and normal or near-normal left ventricular function. Grade 2 (Moderate): Moderate jet size with some effect on the heart, but symptoms may still be absent or minimal. Mild to moderate left ventricular dilation may be present. Grade 3 (Moderately Severe): Larger jet, more significant regurgitation, potentially causing mild heart failure symptoms or moderate dilation of the left ventricle. Grade 4 (Severe): A large, prominent jet of regurgitation that significantly impacts heart function, often resulting in severe symptoms and marked left ventricular dilation. | Pre-Intervention and Post-Intervention (12 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | The number of participants who are deceased will be collected throughout the study at discharge and planned follow up visits. | Post-Intervention (Up to 20 Days), Post-Intervention (Month 6), Post-Intervention (Month 12) |
| Number of Major Adverse Cardiac Events (MACE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Guyton, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25444139 | Background | Kalra K, Wang Q, McIver BV, Shi W, Guyton RA, Sun W, Sarin EL, Thourani VH, Padala M. Temporal changes in interpapillary muscle dynamics as an active indicator of mitral valve and left ventricular interaction in ischemic mitral regurgitation. J Am Coll Cardiol. 2014 Nov 4;64(18):1867-79. doi: 10.1016/j.jacc.2014.07.988. Epub 2014 Oct 27. | |
| 27040451 | Background | Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3. |
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Efforts were made to include post-surgery patients and those from prior years. However, required preoperative imaging was unavailable, preventing preop vs. follow-up comparisons. No participants were enrolled in UMA + PMA (Group 2), and no retrospectively identified patients were included in Group 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | UMA (Group 1) | Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA). Undersizing Mitral Annuloplasty: Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2023 |
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| Papillary Muscle Approximation | Procedure | One or two 4-0 pledgeted sutures are used to draw the two papillary muscle tips together to reduce the inter papillary muscle separation (IPMS) before undergoing undersizing mitral annuloplasty. |
|
MACE is defined as a composite of clinical events comprised of the following:
|
| Up to 12 months post -intervention |
| Change in Quality-of-Life Scale Score | Participants will be asked to measure their perceived quality of life on a scale from 0 to 100 where 0 indicates "worst imaginable health state" and 100 indicates "best imaginable health state". | Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12) |
| Change in Minnesota Living With Heart Failure (MLHF) Questionnaire Score | The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire that asks participants to describe how much their heart failure has affected life during the past month (4 weeks). Participants are asked if their heart failure prevented them from living as they want when completing daily tasks. Responses are rated on a scale from 0 to 5; 0 represents "no", 1 represents "very little" and 5 represents "very much" on a continuum. The MLHF score is obtained by summing the subjects responses. A minimum score is 0 indicating no affect to life and a maximum score is 105 indicating the greatest affect to life. | Baseline, Post-Intervention (Month 12) |
| Change in Functional Status Assessed by 6-Minute Walk Test (6MWT) | Functional status will be measured by a 6-minute walk test, which assesses the distance walked (in feet) on a flat, hard surface in a period of 6 minutes (the 6MWD). The test is used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. Optimal reference equations from healthy population-based samples using standardized 6MWT methods are not yet available. A low 6MWD is nonspecific and nondiagnostic. When the 6MWD is reduced, a thorough search for the cause of the impairment is warranted. | Baseline, Post-intervention (Month 6), Post-Intervention (Month 12) |
| All Cause Readmission Rate | Readmission rate will be calculated for any cause within the first 30 days following surgery throughout the duration of the study. | Post Surgery (Up to 30 Days) |
| Heart Failure Readmission Rate | Readmission rate will be calculated for heart failure after 30 days following surgery throughout the duration of the study. Classification of readmission as heart failure related requires at least 2 out of the following signs and symptoms of acute decompensated heart failure:
| Post Surgery (Up to 30 Days) |
| Change in Left Ventricular Volume | Change in left ventricular volume at 6- and 12-month post-intervention compared to baseline as measured by as measured by the left ventricular end-diastolic diameter determined by echocardiogram. | Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12) |
| Change in Ejection Fraction | Change in left ventricular ejection fraction at 12- months post-intervention compared to baseline as measured by echocardiogram. | Baseline, Post-Intervention (Month 12) |
| Change in Left Ventricular Mass | Change in left ventricular mass at 12 months post intervention compared to baseline as measured by cardiac MRI. | Baseline, Post-Intervention (Month 12) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| 25500293 | Background | Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6. |
| 24245543 | Background | Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL; CTSN. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014 Jan 2;370(1):23-32. doi: 10.1056/NEJMoa1312808. Epub 2013 Nov 18. |
| FG001 |
| UMA + PMA (Group 2) |
Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA). Undersizing Mitral Annuloplasty: Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. Papillary Muscle Approximation: One or two 4-0 pledgeted sutures are used to draw the two papillary muscle tips together to reduce the inter papillary muscle separation (IPMS) before undergoing undersizing mitral annuloplasty. |
| FG002 | No Intervention: Retrospectively Identified Patients | Retrospectively identified patients, who already underwent the standard of care surgery for the lesion of interest at Emory, within 6 months (± 1 month) after their surgery, and suitable for recruitment to the study for their post-operative research. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | UMA (Group 1) | Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA). Undersizing Mitral Annuloplasty: Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in FMR Severity | The Severity (grade 0 to 4+) of mitral regurgitation of mitral regurgitation is measured using cardiac echocardiography and/or MRI (per physician's discretion). Grade 0: None Grade 1 (Mild): Small, restricted jet of regurgitation with minimal impact on the heart's function. Typically, no symptoms and normal or near-normal left ventricular function. Grade 2 (Moderate): Moderate jet size with some effect on the heart, but symptoms may still be absent or minimal. Mild to moderate left ventricular dilation may be present. Grade 3 (Moderately Severe): Larger jet, more significant regurgitation, potentially causing mild heart failure symptoms or moderate dilation of the left ventricle. Grade 4 (Severe): A large, prominent jet of regurgitation that significantly impacts heart function, often resulting in severe symptoms and marked left ventricular dilation. | Data is available only for the 12-month follow-up, as other data was unavailable due to many follow-ups occurring during the COVID pandemic. | Posted | Mean | Standard Deviation | score on a scale | Pre-Intervention and Post-Intervention (12 Months) |
|
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| Secondary | Mortality Rate | The number of participants who are deceased will be collected throughout the study at discharge and planned follow up visits. | Posted | Count of Participants | Participants | Post-Intervention (Up to 20 Days), Post-Intervention (Month 6), Post-Intervention (Month 12) |
|
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| Secondary | Number of Major Adverse Cardiac Events (MACE) | MACE is defined as a composite of clinical events comprised of the following:
| Participants with valid data. | Posted | Count of Participants | Participants | Up to 12 months post -intervention |
|
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| Secondary | Change in Quality-of-Life Scale Score | Participants will be asked to measure their perceived quality of life on a scale from 0 to 100 where 0 indicates "worst imaginable health state" and 100 indicates "best imaginable health state". | Participants who completed the questionnaires within the specific study window. Data is available only for the 12-month follow-up, as other data was unavailable due to many follow-ups occurring during the COVID pandemic. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12) |
|
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| Secondary | Change in Minnesota Living With Heart Failure (MLHF) Questionnaire Score | The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire that asks participants to describe how much their heart failure has affected life during the past month (4 weeks). Participants are asked if their heart failure prevented them from living as they want when completing daily tasks. Responses are rated on a scale from 0 to 5; 0 represents "no", 1 represents "very little" and 5 represents "very much" on a continuum. The MLHF score is obtained by summing the subjects responses. A minimum score is 0 indicating no affect to life and a maximum score is 105 indicating the greatest affect to life. | Participants who answered the specific questionnaires within the specific study window. Data is available only for the 12-month follow-up, as other data was unavailable due to many follow-ups occurring during the COVID pandemic. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Intervention (Month 12) |
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| Secondary | Change in Functional Status Assessed by 6-Minute Walk Test (6MWT) | Functional status will be measured by a 6-minute walk test, which assesses the distance walked (in feet) on a flat, hard surface in a period of 6 minutes (the 6MWD). The test is used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. Optimal reference equations from healthy population-based samples using standardized 6MWT methods are not yet available. A low 6MWD is nonspecific and nondiagnostic. When the 6MWD is reduced, a thorough search for the cause of the impairment is warranted. | Participants who completed the study procedure. Data is available only for the 12-month follow-up, as other data was unavailable due to many follow-ups occurring during the COVID pandemic. | Posted | Mean | Standard Deviation | feet | Baseline, Post-intervention (Month 6), Post-Intervention (Month 12) |
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| Secondary | All Cause Readmission Rate | Readmission rate will be calculated for any cause within the first 30 days following surgery throughout the duration of the study. | Participants with valid data. | Posted | Count of Participants | Participants | Post Surgery (Up to 30 Days) |
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| Secondary | Heart Failure Readmission Rate | Readmission rate will be calculated for heart failure after 30 days following surgery throughout the duration of the study. Classification of readmission as heart failure related requires at least 2 out of the following signs and symptoms of acute decompensated heart failure:
| Participants with valid data. | Posted | Count of Participants | Participants | Post Surgery (Up to 30 Days) |
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| Secondary | Change in Left Ventricular Volume | Change in left ventricular volume at 6- and 12-month post-intervention compared to baseline as measured by as measured by the left ventricular end-diastolic diameter determined by echocardiogram. | Participants with valid data. Data is available only for the 12-month follow-up, as other data was sparse due to many follow-ups occurring during the COVID pandemic. | Posted | Mean | Standard Deviation | centimeters | Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12) |
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| Secondary | Change in Ejection Fraction | Change in left ventricular ejection fraction at 12- months post-intervention compared to baseline as measured by echocardiogram. | Participants who had adequate echocardiograms to complete this evaluation. | Posted | Mean | Standard Deviation | percentage of ejection fraction | Baseline, Post-Intervention (Month 12) |
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| Secondary | Change in Left Ventricular Mass | Change in left ventricular mass at 12 months post intervention compared to baseline as measured by cardiac MRI. | Some MRIs were performed but not analyzed, as these were research trial MRIs. The original PI and a research post-doc who were the expert analysts, left before reading the MRIs. Only eight patients had both pre- and post-MRIs. Outsourcing analysis was too costly, and meaningful comparisons weren't possible with such a small sample, so the MRIs were not read for the study. | Posted | Baseline, Post-Intervention (Month 12) |
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Considering the observational nature of this study, and the absence of any experimental procedures, adverse event (AE) reporting was limited only to those events that occurred from the specific non-standard-of-care lab procedures that were performed at 6- and 12-month visits.
An adverse event (AE) is any undesirable clinical occurrence related to a non-standard-of-care study intervention. Pre-existing or associated Conditions with standard care are not AEs unless they change in nature, severity, or degree. AEs are typically reported in trials involving experimental interventions. In this observational study, AE reporting was limited to events from non-standard-of-care lab procedures at the 6- and 12-month visits, none of which were related to those procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UMA (Group 1) | Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA). Undersizing Mitral Annuloplasty: Participants will receive a commercially available annuloplasty ring of the surgeon's choice. Sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. | 0 | 26 | 4 | 26 | 0 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation + congestive heart failure (CHF) | Cardiac disorders | Non-systematic Assessment | Hospital admission due to Atrial fibrillation + congestive heart failure (CHF) |
| |
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment | Hospital admission due to Atrial Flutter |
| |
| Acute cholecystitis with perforated gallbladder | Gastrointestinal disorders | Non-systematic Assessment | Hospital admission due to acute cholecystitis with perforated gallbladder |
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| Syncope | General disorders | Non-systematic Assessment | Hospital admission due to syncope. |
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Funds were granted for a clinical study led by the original PI, but enrollment halted during the pandemic. Follow-up was difficult, preventing study procedures, and preoperative imaging was lacking, preventing comparisons. The PI left in April 2023, leaving no expert MRI analysts for limited data. Dr. Guyton took over 8 months before the study was terminated. The NIH redirected funding to large animal studies and computational analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Guyton | Emory University | 404 686-4499 | rguyton@emory.edu |
| Nov 5, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2023 | Nov 5, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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