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INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry (INTERPRET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338309
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Seoul National University Hospital
Philips Healthcare
Information provided by (Responsible Party):
Joo Myung Lee, Samsung Medical Center

Brief Summary:
The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.

Condition or disease Intervention/treatment
Stable Angina Non ST Segment Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Silent Myocardial Ischemia Unstable Angina Other: Instantaneous wave-free ratio measurement

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicenter Registry for Instantaneous Wave-Free Ratio (iFR)-Guided Percutaneous Coronary Intervention in Routine Clinical Practice
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Group/Cohort Intervention/treatment
iFR-guied strategy group
1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.
Other: Instantaneous wave-free ratio measurement
Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis




Primary Outcome Measures :
  1. Patient-oriented composite outcome (POCO) [ Time Frame: at 2-year after index procedure ]
    a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus


Secondary Outcome Measures :
  1. Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement [ Time Frame: Immediate after post revascularization ]
    Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.
Criteria

Inclusion Criteria:

  • Subject must be ≥18 years

    • Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.

      • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides

Exclusion Criteria:

  • Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg)

    • Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment).

      • History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia)

        • Patients with active pathologic bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338309


Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Inje University Ilsan Paik Hospital
Goyang, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Seoul National University Hospital
Philips Healthcare
Investigators
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Study Chair: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Study Director: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center
Additional Information:

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Responsible Party: Joo Myung Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03338309    
Other Study ID Numbers: NCT104658359911
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared upon request after thorough discussion in steering committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo Myung Lee, Samsung Medical Center:
Fractional flow reserve
Instantaneous wave-free ratio
Ischemic heart disease
Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Angina, Stable
ST Elevation Myocardial Infarction
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms