Determination of Coronarphysiological Parameters With the Method of Thermodillution

March 25, 2019 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
The gold standard to induce coronary hyperemia for measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is adenosine, but it exerts several side effects due to its unspecific action on adenosine receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary arteries and enables FFR measurements. The aim of the study was to evaluate whether simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within regadenoson-induced hyperemia.

Study Overview

Status

Completed

Conditions

Detailed Description

Fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) provide significant information on the conductance of coronary macro- and microcirculation.

FFR-based functional assessment of coronary artery disease has proven to be superior to purely morphologic assessment and thereby guides therapy decision. IMR is a pressure-temperature derived parameter for quantifying microcirculatory resistance, which has been proven to be relatively independent of epicardial stenosis severity when taking collateral flow into account. IMR is increased in patients with acute myocardial infarction and microvascular obstruction (MVO) as assessed by contrast-enhanced CMR and predicts left ventricular function and enddiastolic volumes at 6 month independently of initial infarct size.

Most interestingly, even in the absence of obstructive coronary artery disease, IMR is elevated in more than 20% of patients presenting with chest pain. The clinical meaning for this finding has to be elucidated.

FFR, CFR and IMR can only be measured under conditions of minimal coronary resistance with the need for coronary hyperemia. The current "gold standard" to induce hyperemia in the assessment of coronary conductance is adenosine. However, adenosine is known to cause side effects (bronchospasm and disturbances in atrioventricular conduction) due to its unselective action on all adenosine receptors. Besides that, adenosine requires a body weight adapted dosing and continuous infusion. However, alternative routes like intracoronary injection show good correlation compared with the intravenous route and side effects can be reduced. In contrast, regadenoson, a specific A2A receptor agonist, exhibits negligible side effects. It can be administered intravenously as a non-body weight adapted bolus via peripheral vein without the need for transfemoral delivery. Thus, patients with a transradial access for cardiac catheterization might benefit the most from inducing hypermedia via peripheral vein. It has already been shown that regadenoson increases coronary blood flow yielding comparable values for FFR and indexes of perfusion in SPECT. However, the duration and stability of regadenoson-induced hyperemia might be insufficient for a simultaneous measurement of FFR, CFR and IMR, which has not been tested so far.

The aim of the present study is to evaluate whether simultaneous measurement of the parameters FFR, CFR and IMR under regadenoson-induced hyperemia is feasible, safe and effective in patients with stable coronary artery disease undergoing a transradial procedure

Study Type

Observational

Enrollment (Actual)

50

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

  • Germany
      • Dusseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for FFR measurement due to a coronary artery stenosis of unclear hemodynamic relevance

Description

Inclusion Criteria:

Coronary angiography with indication of FFR measurement

  • angiography without pathological results explaining the patients' symptoms
  • intermediate stenosis (50-70%)

Exclusion Criteria:

  • <18 years
  • Hypersensitivity towards regadenoson
  • hemodynamic instability
  • severe hypotension
  • acute myocardial ischemia
  • AV block II-III

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fractional flow reserve (FFR)
Time Frame: Baseline
Description: the proximal aortic (Pa) and distal arterial pressure (Pd) are recorded and RadiAnalyzer Xpress™ control unit automatically calculates FFR as Pd/Pa
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coronary flow reserve
Time Frame: Baseline
The RadiAnalyzer Xpress™ calculates CFR as Tmnr/Tmnh
Baseline
index of microcirculatory resistance
Time Frame: Baseline
Using the derived Pd and transit mean times under hyperemia (Tmnh), it will be calculated apparent IMR as Pd×Tmnh. All IMR values are also corrected by Yong's formula (IMRcorr=Pa×Tmnh×([1.35×Pd/Pa]-0.32) to adjust for the influence of collateral flow.
Baseline

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

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 (Actual)

February 5, 2017

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-024 (HMR Protocol Code)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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