Innate Human Collateral Supply to Different Vascular Regions

NCT02063347 | Completed

• 2 other identifiers: 185/132451
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Both clinical and experimental studies demonstrate the importance of the pre-existing, ie innate collateral supply in different vascular regions. Furthermore, pathophysiological considerations and experimental data imply an important role for the association of collateral function between different vascular regions. STUDY HYPOTHESES 1. In the absence of atherosclerotic stenoses, there is a direct association between the collateral function in the coronary, renal and peripheral circulation. 2. The increase in plasma renin in response to a unilateral main renal artery balloon occlusion is inversely related to its functional collateral supply. 3. The decrease in renal vein oxygen saturation in response to a unilateral main renal artery occlusion is inversely related to its functional collateral supply.

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

innate collateral supply; collateral; coronary collateral; renal collateral; peripheral collateral; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Collateral Flow index

  At baseline

Secondary Outcomes (4)

• Intracoronary ST segment elevation

  At baseline

• Transcutaneous oxygen tension (tcpO2)

  At baseline

• Plasma renin concentration

  Before, immediately after and 10 minutes after main renal artery occlusion

• Renal vein oxygen saturation

  Before, during and immediately after main renal artery occlusion

Study Arms (2)

Coronary artery disease

With coronary artery disease

No coronary artery disease

Without coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients electively referred for coronary angiography in the context of chest pain.

You may qualify if:

• Age \> 17 years
• Referred for elective coronary angiography
• Written informed consent to participate in the study

You may not qualify if:

• Acute coronary syndrome
• Severe cardiac valve disease
• Congestive heart failure NYHA III-IV
• History of renal disease with normal renal function/ solitary kidney
• Renal (abnormal serum creatinin level) or hepatic failure
• Peripheral artery disease \> stage I

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Stoller M, Seiler C. Intraindividual Variability and Association of Human Collateral Supply to Different Arterial Regions. Am J Cardiol. 2016 Feb 15;117(4):685-690. doi: 10.1016/j.amjcard.2015.11.026. Epub 2015 Dec 2.

  PMID: 26772443 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Christian Seiler, MD Prof

  Department of Cardiology, Bern University Hospital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 14, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2015-07

Locations

CH (1)