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FFR and Inducible Myocardial Ischemia During Adenosine Stress Testing

Primary Purpose

Coronary Artery Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fractional flow reserve with adenosine stress testing
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Stenosis focused on measuring Coronary artery disease, Myocardial ischemia, Fractional flow reserve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FFR Measurement

Arm Description

Myocardia ischemia evaluation during adenosine stress testing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
July 19, 2021
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04401657
Brief Title
FFR and Inducible Myocardial Ischemia During Adenosine Stress Testing
Official Title
Relationship Between Fractional Flow Reserve and Inducible Myocardial Ischemia During Adenosine Stress Testing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
Coronary artery disease, Myocardial ischemia, Fractional flow reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR Measurement
Arm Type
Experimental
Arm Description
Myocardia ischemia evaluation during adenosine stress testing
Intervention Type
Diagnostic Test
Intervention Name(s)
Fractional flow reserve with adenosine stress testing
Intervention Description
ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.
Primary Outcome Measure Information:
Title
Definite myocardial ischemia
Description
Echocardiographic wall motion score index score by 17-segment model or ST segment elevation/depression by 12-lead ECG during adenosine stress testing
Time Frame
during adenosine stress testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do-Yoon Kang, MD
Phone
82-2-3010-1745
Email
kdy1218@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Whan Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol Whan Lee, MD, PhD
Email
cheolwlee@amc.seoul.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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FFR and Inducible Myocardial Ischemia During Adenosine Stress Testing

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