Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01676207
First received: August 28, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Collateral Circulation
Ischemia
Procedure: Coronary Angiography with collateral flow measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Extracardiac Coronary Collateral Supply Via the Internal Mammary Arteries

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Coronary Collateral Flow Index (CFI) [ Time Frame: during coronary artery balloon occlusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-coronary occlusive ECG ST segment shift (mV) [ Time Frame: at 1 minute of coronary artery balloon occlusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
CAD
Procedure: Coronary 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.
2
no CAD
Procedure: Coronary 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients electively referred for coronary angiography

Criteria

Inclusion Criteria:

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676207

Locations
Switzerland
Department of Cardiology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Christian Seiler, MD Prof Department of Cardiology, Bern University Hospital
  More Information

Additional Information:
No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01676207     History of Changes
Other Study ID Numbers: 007/12
Study First Received: August 28, 2012
Last Updated: January 15, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
coronary collateral circulation
extracardiac coronary collaterals
coronary artery disease
coronary circulation
internal mammary artery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014