Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656065
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
IMR-Heart Trasplant Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Index Microvascular Resistance IMR-guided Management of Heart Transplantation IMR-Heart Transplant Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endomyocardial biopsy EMB is the gold standard method to guide post-heart trasplant HT patients as it represents the best tool to identify rejection in orthotopic HT However it is frequently repeated during the first year with some variations depending on each center protocol and it is potentially associated with serious complicationsSeveral studies have presented the association between acute allograft rejection micro-vasculopathy and cardiac allograft epicardial vasculopathy CAV Index of microvascular resistance IMR measured early after HT has been significantly associated with the risk of acute cellular rejection ACR The aim of this study will be to evaluate if the use of IMR early after HT may improve the patients care after HT by reducing the number of EMB
Detailed Description:
Acute allograft rejection ACR is an important cause of mortality and re-transplantation in heart transplant HT patients particularly during the first year Endomyocardial biopsy EMB is the gold standard to guide post- HT treatment EMB is repeatedly performed during the first year and is associated with complications that despite infrequent can be potentially serious In order to avoid the inconveniences of EMB non-invasive techniques have been studied to detect rejection However none of these techniques has been able to replace EMB Index of microvascular resistance IMR is a specific physiological parameter to measure microvascular function An increased index of microvascular resistance IMR measured early after HT has been associated with ACR a higher all-cause mortality and adverse cardiac events regardless of epicardial vasculopathy According to available data no study has evaluated IMR impact on post-HT management number of EMBs performed The aim of this study will be to evaluate if the use of IMR early after HT may improve the patients care after HT by reducing the number of EMB
The IMR-HT study is a multicenter prospective observational study that will include post-HT stable patients undergoing coronary physiological assessment in the first two months and one year Assessment of IMR coronary flow reserve CFR and fractional flow reserve FFR will be performed using the standard thermodilution technique The left anterior descending coronary artery will be evaluated in all patients Circumflex or right coronary artery could be additionally evaluated at operators discretion An intracoronary pressure and temperature sensor-tipped guidewire Pressure Wire TM X guide- wire 0014 Abbott IL USA will be used to perform the measurements The tip pressure sensor will be advanced into the mid-to-distal portion of the evaluated vessel Baseline aortic pressure Pa and distal intracoronary pressure Pd will be obtained to calculate the resting index PdPa To measure the mean transit time Tmn under basal conditions intracoronary administration of 3 mL of room-temperature saline will be manually injected three times in succession 3 mLs Then maximal hyperemia will be induced using adenosine iv 140 to 180 mgkgmin and three additional intracoronary room temperature saline boluses of 3 ml will be administered to determine the mean transit time at hyperemia Tmnh Finally fractional flow reserve FFR coronary flow reserve CFR and IMR will be calculated using the software Coroventis Coroflow Coroventis Abbott Uppsala Sweden
Depending on IMR values obtained in the first two months clinical status and the other complementary tests the physician could be able to modify the number of biopsies established in each center protocol If the IMR is less than 15 the number of biopsies could be reduced or kept the same No immunosuppressive therapy changes would be made If the IMR is 15 or greater the number of biopsies would be performed as usual per protocol immunosuppressive therapy could be intensified or maintained the same
Clinical conditions laboratory findings and clinical events will be assessed at one month and one year Data will be included in an online database specifically designed for the study on platform REDCap Research Electronic Data CaptureEach center will specify the number of annual biopsies performed based on IMR values obtained between the first two months after HT
A number will be assigned to each patient their identity will not be disclosed in any case All shared information will be anonymized The principal investigator at each center will be responsible for keeping the data anonymizedData will be processed in accordance with the protection legislation in force Spanish Personal Data Protection and Guarantee of Digital Rights Act 32018 and Regulation EU 2016679
The study primary end point will be the number of EMB performed at one year Other secondary endpoints include the association between IMR and mortality ACR cardiac failure re-trasplantation and cardiac allograft vasculopathy Patients will be followed for up to 5 years
The IMR-HT study is a multicenter prospective observational study that will include post-HT stable patients undergoing coronary physiological assessment in the first two months and one year Assessment of IMR coronary flow reserve CFR and fractional flow reserve FFR will be performed using the standard thermodilution technique The left anterior descending coronary artery will be evaluated in all patients Circumflex or right coronary artery could be additionally evaluated at operators discretion An intracoronary pressure and temperature sensor-tipped guidewire Pressure Wire TM X guide- wire 0014 Abbott IL USA will be used to perform the measurements The tip pressure sensor will be advanced into the mid-to-distal portion of the evaluated vessel Baseline aortic pressure Pa and distal intracoronary pressure Pd will be obtained to calculate the resting index PdPa To measure the mean transit time Tmn under basal conditions intracoronary administration of 3 mL of room-temperature saline will be manually injected three times in succession 3 mLs Then maximal hyperemia will be induced using adenosine iv 140 to 180 mgkgmin and three additional intracoronary room temperature saline boluses of 3 ml will be administered to determine the mean transit time at hyperemia Tmnh Finally fractional flow reserve FFR coronary flow reserve CFR and IMR will be calculated using the software Coroventis Coroflow Coroventis Abbott Uppsala Sweden
Depending on IMR values obtained in the first two months clinical status and the other complementary tests the physician could be able to modify the number of biopsies established in each center protocol If the IMR is less than 15 the number of biopsies could be reduced or kept the same No immunosuppressive therapy changes would be made If the IMR is 15 or greater the number of biopsies would be performed as usual per protocol immunosuppressive therapy could be intensified or maintained the same
Clinical conditions laboratory findings and clinical events will be assessed at one month and one year Data will be included in an online database specifically designed for the study on platform REDCap Research Electronic Data CaptureEach center will specify the number of annual biopsies performed based on IMR values obtained between the first two months after HT
A number will be assigned to each patient their identity will not be disclosed in any case All shared information will be anonymized The principal investigator at each center will be responsible for keeping the data anonymizedData will be processed in accordance with the protection legislation in force Spanish Personal Data Protection and Guarantee of Digital Rights Act 32018 and Regulation EU 2016679
The study primary end point will be the number of EMB performed at one year Other secondary endpoints include the association between IMR and mortality ACR cardiac failure re-trasplantation and cardiac allograft vasculopathy Patients will be followed for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None