FFR and Inducible Myocardial Ischemia During Adenosine Stress Testing

July 19, 2021 updated by: CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

Relationship Between Fractional Flow Reserve and Inducible Myocardial Ischemia During Adenosine Stress Testing

This is a prospective, single center study involving 150 patients with stable coronary artery disease undergoing coronary angiography for chest pain evaluation. The relationship between FFR values and inducible myocardial ischemia at the time of definite ischemia during adenosine stress testing will be investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fractional flow reserve (FFR) is commonly used to search for ischemia-producing lesions during percutaneous coronary intervention (PCI), and its assessment becomes an integral part to guide PCI when objective evidences of inducible myocardial ischemia are not available. A transient imbalance between oxygen supply and demand leads to the ischemic cascade, which are typically accompanied by regional wall motion abnormalities or electrocardiographic changes as objective evidences of inducible myocardial ischemia.

FFR is a pressure-derived surrogate of coronary flow limitation defined as the ratio of distal coronary pressure to aortic pressure during maximal hyperemia. FFR has been indirectly validated against noninvasive stress tests, and large outcome trials support the benefit of FFR-guided PCI strategy. However, FFR is not a direct measurement of coronary flow, and myocardial ischemia depends on coronary flow rather than pressure. In fact, an experimental model shows that myocardial function can be maintained without evidences of myocardial ischemia despite low FFR. Furthermore, FFR did not predict improvement in symptoms or exercise performance after PCI, challenging the current threshold of FFR for discriminating ischemia-producing lesions.

The clinical benefit of FFR-guided PCI is certainly related to relief of inducible myocardial ischemia. However, there is little information to examine a direct link between FFR values and documented inducible ischemia at the time of FFR measurement. Therefore, the investigators investigate the relationship between FFR values and inducible myocardial ischemia at the time of definite ischemia during adenosine stress testing.

A 12-lead ECG recordings, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion. When new regional wall motion abnormalities in echocardiography develop, adenosine infusion is ended and echocardiographic monitoring will be continued until left ventricular wall motion returns to normal. Apical (two-chamber, four-chamber and five chamber views) and parasternal long-axis and short-axis views will be recorded for offline analysis.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • Men or women at least 18 years of age
  • Patients undergoing coronary angiography
  • Moderate to severe stenosis (diameter stenosis equal or more than 50 percent by visual examination) in one major epicardial coronary artery
  • Normal left ventricular function without regional wall motion abnormality

Exclusion Criteria:

  • Contraindications to adenosine stress test*
  • ECG abnormalities (bundle branch block, LVH with strain, pacing rhythm, WPW)
  • History of previous myocardial infarction
  • Significant multi-vessel coronary artery disease (diameter stenosis equal or more than 50%)
  • Hypertrophic cardiomyopathy
  • Significant valvular heart disease
  • Bronchial asthma or chronic obstructive lung disease
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  • Current treatment for the active cancer
  • Expected life expectancy < 1 year
  • Unwillingness or inability to comply with the procedures described in this protocol.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FFR Measurement
Myocardia ischemia evaluation during adenosine stress testing
Diagnostic test: Fractional flow reserve with adenosine stress testing
ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Definite myocardial ischemia
Time Frame: during adenosine stress testing
Echocardiographic wall motion score index score by 17-segment model or ST segment elevation/depression by 12-lead ECG during adenosine stress testing
during adenosine stress testing

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Cheol Whan Lee, MD, PhD, Asan Medical Center

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)

May 8, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR_Ischemia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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