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CompletedNCT01676207Updated Jan 16, 2014

Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries

An observational study in Coronary Artery Disease, Collateral Circulation and Ischemia, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-16.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

  • 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.
02

Conditions studied

  • Coronary Artery Disease
  • Collateral Circulation
  • Ischemia

Keywords

  • coronary collateral circulation
  • extracardiac coronary collaterals
  • coronary artery disease
  • coronary circulation
  • internal mammary artery
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 120 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients electively referred for coronary angiography

Inclusion criteria

  • age > 17 years
  • electively referred for coronary angiography
  • written informed consent to participate in the study

Exclusion criteria

Exclusion Criteria

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (actual)

Groups and cohorts

  • 1

    CAD

    Procedure: Coronary Angiography with collateral flow measurements

  • 2

    no CAD

    Procedure: Coronary Angiography with collateral flow measurements

Interventions

  • ProcedureCoronary Angiography with collateral flow measurements

    * 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.

  • ProcedureCoronary Angiography with collateral flow measurements

    * 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.

06

What researchers measure

Primary outcomes

  1. Coronary Collateral Flow Index (CFI)

    Time frame: during coronary artery balloon occlusion

Secondary outcomes

  1. Intra-coronary occlusive ECG ST segment shift (mV)

    Time frame: at 1 minute of coronary artery balloon occlusion

  2. angiographic visibility of coronary collateral supply via the internal mammary artery during their distal balloon occlusion

    Time frame: at 1 minute of coronary artery balloon occlusion

07

Study locations

1 site
  • Department of Cardiology, Bern University Hospital
    Bern, 3010, Switzerland
08

References and documents

Publications

  • 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. PubMed 24744276 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01676207
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Jul 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 16, 2014

Study contacts

Christian Seiler, MD Prof
principal investigator · Department of Cardiology, Bern University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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