Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474754
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Brief Title:
Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Enhancing Precise Perioperative Risk Surveillance Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnhanceMINS
Brief Summary:
The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing The main questions are
Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care
And which submaximal cardiopulmonary exercise testing measure is better
Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test then undergo surgery Myocardial injury will be measured on postoperative days 0 1 2 and 3 during and up to 3 days after surgery These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test
If there is a relationship this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery
Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care
And which submaximal cardiopulmonary exercise testing measure is better
Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test then undergo surgery Myocardial injury will be measured on postoperative days 0 1 2 and 3 during and up to 3 days after surgery These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test
If there is a relationship this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery
Detailed Description:
Among the 50 million US adults undergo non-cardiac surgery each year an estimated 14-39 of patients experience perioperative myocardial infarction with another 6-18 showing evidence of myocardial injury These cardiac insults known as myocardial injury after noncardiac surgery MINS are associated with a 27-32 fold higher odds of 30-day mortality 22 fold higher odds of nonfatal myocardial infarction MI 155 fold increase in 30-day congestive heart failure events and 52 times higher risk of stroke highlighting the importance of predicting and treating their occurrence MINS is treatable and potentially preventable by a combination of tailored intraoperative monitoring and appropriate post-operative care
The current approach to preoperative risk stratification is predominately derived from patient-reported functional capacity associated with history physical examination and select laboratory investigations This approach results in significant healthcare worker time and cost expenditures without improved perioperative outcomes In contrast a technological approach utilizing conventional cardiopulmonary exercise testing CPET has been shown to improve individualized identification of high-risk patients prior to surgery Widespread cardiopulmonary exercise test adoption in the perioperative setting however has been limited by cost technical requirements and time investment despite its documented utility in cardiopulmonary risk assessment However brief submaximal cardiopulmonary exercise testing smCPET addresses the limitations of conventional CPET including low cost low time investment small footprint and ease of operator efficiency In our pilot under review we demonstrated the feasibility and performance of implementing smCPET within a high-volume pre-surgical evaluation clinic
This proposal seeks to continue work in characterizing smCPET and its role in individualized preoperative risk identification The aim of this study proposal is to validate two clinically relevant questions 1 Are smCPET measures superior to usual care Duke Activity Status Index in patients undergoing moderate to high-risk noncardiac surgery and 2 to determine which smCPET measure is more sensitive to MINS as described by abnormalities in postoperative high-sensitivity troponin measurements
Using a smCPET-guided approach we seek to characterize its value in identifying high-risk patients for MINS provide further validation of smCPET utility as a preoperative risk stratification approach and preliminarily identify smCPET measures with highest association with MINS
If validated this would provide the foundation for a smCPET-guided clinical decision support system of preoperative identification and perioperative monitoring that could 1 enhance patient outcomes by providing early prediction and detection of MINS and 2 characterize a research methodology to stratify participants for further research in assessing perioperative strategies to reduce MINS These findings will provide one of the first examples of quantitative and individualized preoperative risk identification methods for a common and deleterious perioperative outcome
The current approach to preoperative risk stratification is predominately derived from patient-reported functional capacity associated with history physical examination and select laboratory investigations This approach results in significant healthcare worker time and cost expenditures without improved perioperative outcomes In contrast a technological approach utilizing conventional cardiopulmonary exercise testing CPET has been shown to improve individualized identification of high-risk patients prior to surgery Widespread cardiopulmonary exercise test adoption in the perioperative setting however has been limited by cost technical requirements and time investment despite its documented utility in cardiopulmonary risk assessment However brief submaximal cardiopulmonary exercise testing smCPET addresses the limitations of conventional CPET including low cost low time investment small footprint and ease of operator efficiency In our pilot under review we demonstrated the feasibility and performance of implementing smCPET within a high-volume pre-surgical evaluation clinic
This proposal seeks to continue work in characterizing smCPET and its role in individualized preoperative risk identification The aim of this study proposal is to validate two clinically relevant questions 1 Are smCPET measures superior to usual care Duke Activity Status Index in patients undergoing moderate to high-risk noncardiac surgery and 2 to determine which smCPET measure is more sensitive to MINS as described by abnormalities in postoperative high-sensitivity troponin measurements
Using a smCPET-guided approach we seek to characterize its value in identifying high-risk patients for MINS provide further validation of smCPET utility as a preoperative risk stratification approach and preliminarily identify smCPET measures with highest association with MINS
If validated this would provide the foundation for a smCPET-guided clinical decision support system of preoperative identification and perioperative monitoring that could 1 enhance patient outcomes by providing early prediction and detection of MINS and 2 characterize a research methodology to stratify participants for further research in assessing perioperative strategies to reduce MINS These findings will provide one of the first examples of quantitative and individualized preoperative risk identification methods for a common and deleterious perioperative outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None