Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries
1 other identifier
observational
120
1 country
1
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 literature,the 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2012
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 16, 2014
January 1, 2014
1.4 years
August 28, 2012
January 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coronary Collateral Flow Index (CFI)
during coronary artery balloon occlusion
Secondary Outcomes (2)
Intra-coronary occlusive ECG ST segment shift (mV)
at 1 minute of coronary artery balloon occlusion
angiographic visibility of coronary collateral supply via the internal mammary artery during their distal balloon occlusion
at 1 minute of coronary artery balloon occlusion
Study Arms (2)
1
CAD
2
no CAD
Interventions
* Diagnostic coronary angiography and LV angiography * Administration of 5'000 units of heparin i.v. 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.
Eligibility Criteria
Patients electively referred for coronary angiography
You may qualify if:
- age \> 17 years
- electively referred for coronary angiography
- written informed consent to participate in the study
You may not qualify if:
- Acute coronary syndrome
- Prior coronary artery bypass grafting
- Severe cardiac valve disease
- Congestive heart failure NYHA III-IV
- Severe pulmonary artery hypertension
- Severe hepatic or renal failure (creatinine clearance \< 15ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Bern University Hospital
Bern, 3010, Switzerland
Related Publications (1)
Stoller M, de Marchi SF, Seiler C. Function of natural internal mammary-to-coronary artery bypasses and its effect on myocardial ischemia. Circulation. 2014 Jun 24;129(25):2645-52. doi: 10.1161/CIRCULATIONAHA.114.008898. Epub 2014 Apr 17.
PMID: 24744276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Seiler, MD Prof
Department of Cardiology, Bern University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 16, 2014
Record last verified: 2014-01