Assessment of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements

October 22, 2019 updated by: Afshin Farzaneh-Far, University of Illinois at Chicago

Assessment and Prognostic Significance of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements During Regadenoson Stress Cardiac Magnetic Resonance

The aim of this study is to assess whether myocardial perfusion reserve, measured during routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in the heart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress vs. rest. Traditionally, it has been measured non-invasively using quantitative positron emission tomography (PET) or cardiac magnetic resonance (CMR). Several recent studies have suggested that measurement of myocardial perfusion reserve provides significant additive prognostic information during stress perfusion imaging in patients with known or suspected coronary artery disease. Myocardial perfusion reserve depends not only on trans-stenotic pressure gradient of the epicardial arteries and thus stenosis severity but even more on the ability of the coronary microvasculature (especially the pre-arterioles) to dilate. Therefore, coronary microvascular dysfunction, which impairs pre-arteriolar function, reduces myocardial perfusion reserve independently of the presence of epicardial coronary stenosis. Hence, the ability to measure myocardial perfusion reserve allows a more comprehensive assessment of the entire coronary circulation, beyond the current paradigm of the epicardial arteries.

However, both PET and current CMR techniques are cumbersome, and in the case of PET require radiation as well as on-site Rubidium-82 generators. Therefore, they are challenging for routine clinical practice and have been limited to specialized research centers. An alternative, simple CMR method for measurement of myocardial perfusion reserve by quantifying change in coronary sinus flow has been described. The coronary sinus drains approximately 96% of total myocardial blood flow and provides a potentially convenient location for measurement of global myocardial blood flow. This method has been validated against both invasive and PET techniques. The investigators hypothesized that measurement of coronary sinus flow at stress and rest may provide a simple and rapid assessment of myocardial perfusion reserve during regadenoson stress perfusion CMR.

This study will use phase contrast images obtained from patients during their clinically indicated CMR stress study to calculate myocardial perfusion reserve as the ratio of maximum myocardial blood flow to baseline blood flow - at the coronary sinus. Coronary sinus flow will be calculated by post-processing of images after the patient has left the scanner. In brief, the contour of the coronary sinus will be traced on the flow images throughout the cardiac cycle. Coronary sinus flow is calculated by integrating the momentary flow rate values from each cardiac phase over the entire cardiac cycle and multiplying by the mean heart rate during the acquisition. Patients will be followed for the occurrence of major adverse cardiac events (death, myocardial infarction, late revascularization, hospitalization for heart failure or unstable angina).

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • 1740 W Taylor Street, 2nd Floor, Cardiac Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients ≥ 18yrs who are undergoing clinically indicated stress cardiac magnetic resonance (CMR) imaging for known or suspected coronary artery disease.

Description

Inclusion Criteria:

  • Age ≥18
  • Male or Female
  • Referred for clinical cardiac magnetic resonance stress testing (with Regadenoson) at the University of Illinois Hospital & Health Sciences System by their healthcare provider as part of their routine clinical care for known or suspected coronary artery disease.

Exclusion Criteria:

  • Presence of metallic implants contraindicated with cardiac magnetic resonance (e.g. implantable cardiac defibrillator, pacemaker)
  • Glomerular Filtration Rate (GFR) <30ml/min
  • High degree atrio-ventricular block
  • Hypersensitivity to Regadenoson
  • Severe active wheezing from asthma
  • Severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with known or suspected coronary artery disease.
Patients with known or suspected coronary artery disease undergoing clinically ordered stress cardiac magnetic resonance imaging.
Drug: Regadenoson

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events
Time Frame: For upto 24 months
For upto 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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