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Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR (IMPACT-FFR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030495
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Seoul National University Hospital
Inje University
Ulsan University Hospital
Keimyung University Dongsan Medical Center
Information provided by (Responsible Party):
Joo-Yong Hahn, Samsung Medical Center

Brief Summary:
  1. To compare the risk of atherosclerotic lesion progression and subsequent patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven repeat revascularization) between deferred lesions with or without over microvascular disease, defined as physiological classification
  2. To explore independent predictors of atherosclerotic lesion progression in deferred lesions based on fractional flow reserve-guided strategy and treated by contemporary medical treatment

Condition or disease Intervention/treatment
Ischemic Heart Disease Device: Comprehensive physiologic evaluation Device: Intravascular imaging devices

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: IMaging and Physiologic Predictors of Atherosclerotic Progression in Deferred Lesions With Contemporary Medical Treatment Based on Fractional Flow Reserve-guided Strategy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overt microvascular disease
Fractional flow reserve>0.80, coronary flow reserve<2 & Index of microvascular resistance>25U
Device: Comprehensive physiologic evaluation
Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
Other Name: Comprehensive physiologic evaluation using pressure-temperature sensor wire

Device: Intravascular imaging devices
Intravascular ultrasound or optical coherence tomography
Other Name: Intravascular ultrasound or optical coherence tomography

No Overt microvascular disease
Fractional flow reserve>0.80, coronary flow reserve>2 & Index of microvascular resistance<25U
Device: Comprehensive physiologic evaluation
Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
Other Name: Comprehensive physiologic evaluation using pressure-temperature sensor wire

Device: Intravascular imaging devices
Intravascular ultrasound or optical coherence tomography
Other Name: Intravascular ultrasound or optical coherence tomography




Primary Outcome Measures :
  1. patient-oriented composite outcome [ Time Frame: 24 months ]
    a composite of all-cause death, MI, any repeat revascularization


Secondary Outcome Measures :
  1. patient-oriented composite outcome [ Time Frame: 12 months ]
    a composite of all-cause death, MI, any repeat revascularization

  2. patient-oriented composite outcome [ Time Frame: 60 months ]
    a composite of all-cause death, MI, any repeat revascularization

  3. All-cause death [ Time Frame: 24 months ]
    All-cause death

  4. cardiac death [ Time Frame: 24 months ]
    cardiac death

  5. Target-vessel nonfatal MI [ Time Frame: 24 months ]
    Target-vessel nonfatal MI

  6. Non-target vessel nonfatal MI [ Time Frame: 24 months ]
    Non-target vessel nonfatal MI

  7. All-cause nonfatal MI [ Time Frame: 24 months ]
    All-cause nonfatal MI

  8. Seattle Angina Questionnaires [ Time Frame: 24 months ]
    Angina severity measured with Seattle Angina Questionnaires

  9. Change in normalized total atheroma volume [ Time Frame: 12 months ]
    TAVnormalized = [Σ (EEM CSA - lumen CSA) / no. of images in pullback images in cohort] X median no. of images in cohort

  10. Change in total atheroma volume index [ Time Frame: 12 months ]
    Indexed total atheroma volume (TAVi): Σ(EEM CSA -lumen CSA)/plaque length

  11. Change in fibrous cap thickness by OCT [ Time Frame: 12 months ]
    Change in fibrous cap thickness by OCT at 12-month

  12. Change in Plaque burden at minimum lumen area site [ Time Frame: 12 months ]
    Change in Plaque burden at minimum lumen area site at 12-month Plaque burden = (EEM-MLA)/EEM x 100

  13. Change in Fractional flow reserve [ Time Frame: 12 months ]
    Change in Fractional flow reserve at 12-month

  14. Change in coronary flow reserve [ Time Frame: 12 months ]
    Change in coronary flow reserve at 12-month

  15. Change in index of microcirculatory resistance [ Time Frame: 12 months ]
    Change in index of microcirculatory resistance at 12-month



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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
Patients with intermediate degree of stenosis (30-70% stenosis by visual estimation) with fractional flow reserve of >0.80 in major epicardial coronary artery amenable to stent implantation or vessel size ≥2.5 mm.
Criteria

Inclusion Criteria:

  • Subject must be ≥ 18 years
  • Patients suspected with ischemic heart disease
  • Patients with intermediate degree of stenosis (30-70% stenosis by visual estimation) with fractional flow reserve of >0.80 in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm
  • Patients whose coronary stenosis were evaluated by invasive imaging techniques (intravascular ultrasound and optical coherence tomography) and physiologic assessment (coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve)
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and he/she or his/her legally authorized representative provides written informed consent to any study related procedure

Exclusion Criteria:

  • End-staged renal disease on peritoneal dialysis or hemodialysis (estimated GFR < 15mL/min)
  • Acute hepatic injury
  • Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg)
  • The patient has a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor
  • Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment)
  • Unable to perform invasive imaging study (intravascular ultrasound and optical coherence tomography) or physiologic assessment (coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve)

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): NCT03030495


Contacts
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Contact: Joo-Yong Hahn, MD, PhD ichjy1@gmail.com
Contact: Joo Myung Lee, MD, MPH, PhD drone80@hanmail.net

Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD,PhD       namcwcv@gmail.com   
Principal Investigator: Chang-Wook Nam, MD,PhD         
Inje University Ilsan Paik Hospital Recruiting
Goyang-si, Korea, Republic of
Contact: Joon-Hyung Doh, MD, PhD       joon.doh@gmail.com   
Principal Investigator: Joon-Hyung Doh, MD, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo-Yong Hahn, MD, PhD       ichjy1@gmail.com   
Contact: Joo Mung Lee, MD,MPH,PhD       drone80@hanmail.net   
Sub-Investigator: Young Bin Song, MD, PhD         
Sub-Investigator: Taek Kyu Park, MD         
Sub-Investigator: Jeong Hoon Yang, MD, PhD         
Principal Investigator: Joo-Yong Hahn, MD, PhD         
Principal Investigator: Joo Mung Lee, MD,MPH,PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MD, PhD       bkkoo@snu.ac.kr   
Contact: Joo Myung Lee, MD, MPH, PhD       drone80@hanmail.net   
Principal Investigator: Bon-Kwon Koo, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Seoul National University Hospital
Inje University
Ulsan University Hospital
Keimyung University Dongsan Medical Center
Investigators
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Study Chair: Joo-Yong Hahn, MD, PhD Samsung Medical Center
Study Chair: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Principal Investigator: Joo-Yong Hahn, MD, PhD Samsung Medical Center
Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center
Additional Information:

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Responsible Party: Joo-Yong Hahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03030495    
Other Study ID Numbers: IMPACT16453143
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Keywords provided by Joo-Yong Hahn, Samsung Medical Center:
Ischemic Heart Disease
Stable angina
Fractional flow reserve
Index of Microcirculatory Resistance
Coronary Flow Reserve
Intravascular Imaging
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases