Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01676207
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2012-08-28
Brief Title:
Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries
Status:
COMPLETED
Status Verified Date:
2014-01
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:
None
Brief Summary:
In contrast to the extensively studied coronary collateral circulation within the heart clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses Usually this has been in the form of case reports giving account of angiographically visible anastomoses between the coronary circulation and the internal mammary artery IMA typically in the presence of a chronic occlusion of a coronary artery In the anatomical literaturethe most common types of extracardiac anastomoses include bronchial-to-coronary-artery and IMA-to-coronary-artery connections Anastomoses between the IMA and the coronary circulation have been documented to occur in 12 of post-mortem patients with CAD
Importantly hitherto existing observations typically have relied on visual methods insensitive for the adequate detection especially of structurally present but poorly functional anastomoses On a diagnostic coronary angiogram collaterals are visible only if the recipient vessel is subtotally stenotic or fully occluded or can be rendered visible during coronary spasm or by temporary balloon occlusion of the recipient artery and simultaneous injection of contrast medium into the other arteries respectively Similarly the macroscopic pathologic postmortem examination is likely to underestimate the true number of extracardiac coronary collaterals
The purpose of this study is to determine the in vivo prevalence and functional distribution of IMA-to-coronary collateral supply via both the right and the left coronary artery
Importantly hitherto existing observations typically have relied on visual methods insensitive for the adequate detection especially of structurally present but poorly functional anastomoses On a diagnostic coronary angiogram collaterals are visible only if the recipient vessel is subtotally stenotic or fully occluded or can be rendered visible during coronary spasm or by temporary balloon occlusion of the recipient artery and simultaneous injection of contrast medium into the other arteries respectively Similarly the macroscopic pathologic postmortem examination is likely to underestimate the true number of extracardiac coronary collaterals
The purpose of this study is to determine the in vivo prevalence and functional distribution of IMA-to-coronary collateral supply via both the right and the left coronary artery
Detailed Description:
Background
Surgical bypass creates an artificial anastomosis between a diseased coronary artery and an extracardiac vessel Often one of the internal mammary arteries IMA is used for this procedure These connections have been very rarely described to occur naturally representing extracardiac coronary collaterals
In contrast to the extensively studied coronary collateral circulation within the heart clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses Usually this has been in the form of case reports giving account of angiographically visible anastomoses between the coronary circulation and the internal mammary artery IMA typically in the presence of a chronic occlusion of a coronary artery In the anatomical literaturethe most common types of extracardiac anastomoses include bronchial-to-coronary-artery and IMA-to-coronary-artery connections Anastomoses between the IMA and the coronary circulation have been documented to occur in 12 of post-mortem patients with CAD
Importantly hitherto existing observations typically have relied on visual methods insensitive for the adequate detection especially of structurally present but poorly functional anastomoses On a diagnostic coronary angiogram collaterals are visible only if the recipient vessel is subtotally stenotic or fully occluded or can be rendered visible during coronary spasm or by temporary balloon occlusion of the recipient artery and simultaneous injection of contrast medium into the other arteries respectively Similarly the macroscopic pathologic postmortem examination is likely to underestimate the true number of extracardiac coronary collaterals
When present pre-existing connections between the IMA and the coronary circulation could be promoted to serve as natural bypasses to diseased coronary arteries Promotion of extracardiac blood flow to the coronary circulation has very rarely already been attempted in the past In a minimally invasive intervention bilateral surgical ligation of both IMA was performed in a few patients resulting in clinical improvement and disappearance of angina However with the advent of coronary surgery efforts aimed at promotion of naturally existing bypasses have been abandoned for the placing of artificially created extracardiac anastomoses to the coronary circulation
Yet with the limitations of these established revascularization interventions becoming clear the need to search for alternative treatment options gets evident Therapeutic arteriogenesis with promotion of naturally existing bypasses between the coronary circulation and the internal mammary arteries presents a future possibility
Objective
The purpose of this study is to determine the in vivo prevalence and functional distribution of IMA-to-coronary collateral supply via both the right and the left coronary artery
Methods
Comparative observational study with CFI measurements in the IMAs proximal IMA occlusion and in the coronary circulation distal IMA occlusion and IMA angiography during distal IMA occlusion
Study Protocol
Diagnostic coronary angiography and LV angiography
Administration of 5000 units of heparin iv and 2 puffs of oral isosorbide-dinitrate
Right and left IMA CFI during a 1-minute ostial vessel occlusion
Selection of the coronary artery for CFI according to stenotic lesion chosen for PCI or according to ease of access by the pressure sensor wire Placement of a non-sensor wire in the left IMA Two coronary CFI measurements 1-minute occlusion the first with the second without distal IMA balloon occlusion Placement of a non-sensor wire in the right IMA Two coronary CFI measurements the first with the second without distal IMA balloon occlusion
IMA angiography left and right during distal IMA and coronary occlusion
Surgical bypass creates an artificial anastomosis between a diseased coronary artery and an extracardiac vessel Often one of the internal mammary arteries IMA is used for this procedure These connections have been very rarely described to occur naturally representing extracardiac coronary collaterals
In contrast to the extensively studied coronary collateral circulation within the heart clinical attention has been paid only anecdotally to extracardiac-to-coronary anastomoses Usually this has been in the form of case reports giving account of angiographically visible anastomoses between the coronary circulation and the internal mammary artery IMA typically in the presence of a chronic occlusion of a coronary artery In the anatomical literaturethe most common types of extracardiac anastomoses include bronchial-to-coronary-artery and IMA-to-coronary-artery connections Anastomoses between the IMA and the coronary circulation have been documented to occur in 12 of post-mortem patients with CAD
Importantly hitherto existing observations typically have relied on visual methods insensitive for the adequate detection especially of structurally present but poorly functional anastomoses On a diagnostic coronary angiogram collaterals are visible only if the recipient vessel is subtotally stenotic or fully occluded or can be rendered visible during coronary spasm or by temporary balloon occlusion of the recipient artery and simultaneous injection of contrast medium into the other arteries respectively Similarly the macroscopic pathologic postmortem examination is likely to underestimate the true number of extracardiac coronary collaterals
When present pre-existing connections between the IMA and the coronary circulation could be promoted to serve as natural bypasses to diseased coronary arteries Promotion of extracardiac blood flow to the coronary circulation has very rarely already been attempted in the past In a minimally invasive intervention bilateral surgical ligation of both IMA was performed in a few patients resulting in clinical improvement and disappearance of angina However with the advent of coronary surgery efforts aimed at promotion of naturally existing bypasses have been abandoned for the placing of artificially created extracardiac anastomoses to the coronary circulation
Yet with the limitations of these established revascularization interventions becoming clear the need to search for alternative treatment options gets evident Therapeutic arteriogenesis with promotion of naturally existing bypasses between the coronary circulation and the internal mammary arteries presents a future possibility
Objective
The purpose of this study is to determine the in vivo prevalence and functional distribution of IMA-to-coronary collateral supply via both the right and the left coronary artery
Methods
Comparative observational study with CFI measurements in the IMAs proximal IMA occlusion and in the coronary circulation distal IMA occlusion and IMA angiography during distal IMA occlusion
Study Protocol
Diagnostic coronary angiography and LV angiography
Administration of 5000 units of heparin iv and 2 puffs of oral isosorbide-dinitrate
Right and left IMA CFI during a 1-minute ostial vessel occlusion
Selection of the coronary artery for CFI according to stenotic lesion chosen for PCI or according to ease of access by the pressure sensor wire Placement of a non-sensor wire in the left IMA Two coronary CFI measurements 1-minute occlusion the first with the second without distal IMA balloon occlusion Placement of a non-sensor wire in the right IMA Two coronary CFI measurements the first with the second without distal IMA balloon occlusion
IMA angiography left and right during distal IMA and coronary occlusion
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