NCT01676207

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

1.4 years

First QC Date

August 28, 2012

Last Update Submit

January 15, 2014

Conditions

Keywords

coronary collateral circulationextracardiac coronary collateralscoronary artery diseasecoronary circulationinternal mammary artery

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

Procedure: Coronary Angiography with collateral flow measurements

2

no CAD

Procedure: Coronary Angiography with collateral flow measurements

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Coronary Artery DiseaseIschemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Seiler, MD Prof

    Department of Cardiology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations