Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries
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| First Received Date ICMJE | August 28, 2012 | ||||||||
| Last Updated Date | March 6, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Coronary Collateral Flow Index (CFI) [ Time Frame: during coronary artery balloon occlusion ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01676207 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries | ||||||||
| Official Title ICMJE | Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries | ||||||||
| 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. |
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| 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 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. 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
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients electively referred for coronary angiography |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Coronary Angiography with collateral flow measurements
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | August 2014 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01676207 | ||||||||
| Other Study ID Numbers ICMJE | 007/12 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital Inselspital, Berne | ||||||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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