Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02475408
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2015-01-05
Brief Title:
Effect of Permanent Internal Mammary Artery Occlusion on Extracardiac Coronary Collateral Supply
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Effect of Permanent Internal Mammary Artery Occlusion on Extracardiac Coronary Collateral Supply
Status:
COMPLETED
Status Verified Date:
2015-06
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:
IMAO
Brief Summary:
Coronary artery disease and the benefit of bypasses
Despite considerable advances in medicine cardiovascular diseases remain the number one cause of death globally primarily consequence of myocardial infarction MI Coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events In this regard the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD as well as to control symptoms is attractive
Durable promotion of coronary collateral circulation
Before the advent of coronary artery bypass grafting permanent augmentation of coronary collateral supply by a single structural modification has already been attempted Bilateral ligation of the internal mammary arteries IMA was performed in CAD patients to alleviate angina pectoris and electrocardiographic ECG signs of ischemia The prevalent in vivo function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for the first time - been recently demonstrated by our research group The acute functional changes observed in response to temporary distal IMA balloon occlusion are expected to result in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the distal IMA is permanently occluded In contrast to the previously employed arteriogenic approaches in humans the attractiveness of such an intervention lies in the potential durability of the effect
In a first step catheter-based IMA occlusion ought to be conceptually investigated in the setting of the less frequently grafted right IMA among patients with ischemia in the right coronary artery territory
Despite considerable advances in medicine cardiovascular diseases remain the number one cause of death globally primarily consequence of myocardial infarction MI Coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events In this regard the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD as well as to control symptoms is attractive
Durable promotion of coronary collateral circulation
Before the advent of coronary artery bypass grafting permanent augmentation of coronary collateral supply by a single structural modification has already been attempted Bilateral ligation of the internal mammary arteries IMA was performed in CAD patients to alleviate angina pectoris and electrocardiographic ECG signs of ischemia The prevalent in vivo function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for the first time - been recently demonstrated by our research group The acute functional changes observed in response to temporary distal IMA balloon occlusion are expected to result in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the distal IMA is permanently occluded In contrast to the previously employed arteriogenic approaches in humans the attractiveness of such an intervention lies in the potential durability of the effect
In a first step catheter-based IMA occlusion ought to be conceptually investigated in the setting of the less frequently grafted right IMA among patients with ischemia in the right coronary artery territory
Detailed Description:
Coronary artery disease and the benefit of bypasses
Despite considerable advances in medicine cardiovascular diseases remain the number one cause of death globally primarily consequence of myocardial infarction MI Although widely used in stable CAD percutaneous coronary intervention PCI has not been shown to reduce the incidence of myocardial infarction or death In contrast coronary artery bypass grafting CABG significantly reduced rates of death and myocardial infarction compared to PCI Similarly coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events In this regard the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD as well as to control symptoms is attractive
Durable promotion of coronary collateral circulation
While a multitude of interventions has been shown to be effective in collateral growth promotion so far the effect of current interventions is only temporary and therefore recurrent application is necessary to sustain the level of collaterals However before the advent of coronary artery bypass grafting permanent augmentation of coronary collateral supply by a single structural modification has already been attempted Bilateral ligation of the internal mammary arteries IMA was performed in CAD patients to alleviate angina pectoris and electrocardiographic ECG signs of ischemia The prevalent in vivo function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for the first time - been recently demonstrated by our research group Levels of collateral function and myocardial ischemia were determined during two coronary balloon occlusions the first with the second without distal IMA balloon occlusion Coronary collateral function was consistently increased in the presence vs the absence of distal ipsilateral IMA balloon occlusion These findings were corroborated by the observed reduction in ischemia Conversely with distal contralateral IMA occlusion collateral function and ECG signs of ischemia remained unchanged The acute functional changes observed in response to temporary distal IMA balloon occlusion are expected to result in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the distal IMA is permanently occluded In contrast to the previously employed arteriogenic approaches in humans the attractiveness of such an intervention lies in the potential durability of the effect
In a first step catheter-based IMA occlusion ought to be conceptually investigated in the setting of the less frequently grafted right IMA among patients with ischemia in the right coronary artery territory
Despite considerable advances in medicine cardiovascular diseases remain the number one cause of death globally primarily consequence of myocardial infarction MI Although widely used in stable CAD percutaneous coronary intervention PCI has not been shown to reduce the incidence of myocardial infarction or death In contrast coronary artery bypass grafting CABG significantly reduced rates of death and myocardial infarction compared to PCI Similarly coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events In this regard the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD as well as to control symptoms is attractive
Durable promotion of coronary collateral circulation
While a multitude of interventions has been shown to be effective in collateral growth promotion so far the effect of current interventions is only temporary and therefore recurrent application is necessary to sustain the level of collaterals However before the advent of coronary artery bypass grafting permanent augmentation of coronary collateral supply by a single structural modification has already been attempted Bilateral ligation of the internal mammary arteries IMA was performed in CAD patients to alleviate angina pectoris and electrocardiographic ECG signs of ischemia The prevalent in vivo function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for the first time - been recently demonstrated by our research group Levels of collateral function and myocardial ischemia were determined during two coronary balloon occlusions the first with the second without distal IMA balloon occlusion Coronary collateral function was consistently increased in the presence vs the absence of distal ipsilateral IMA balloon occlusion These findings were corroborated by the observed reduction in ischemia Conversely with distal contralateral IMA occlusion collateral function and ECG signs of ischemia remained unchanged The acute functional changes observed in response to temporary distal IMA balloon occlusion are expected to result in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the distal IMA is permanently occluded In contrast to the previously employed arteriogenic approaches in humans the attractiveness of such an intervention lies in the potential durability of the effect
In a first step catheter-based IMA occlusion ought to be conceptually investigated in the setting of the less frequently grafted right IMA among patients with ischemia in the right coronary artery territory
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