Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR

NCT03030495 | Active Not Recruiting DMC

• 1 other identifier: IMPACT16453143
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 4

Brief Summary

1. 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. 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

Conditions

Ischemic Heart Disease

Keywords

Ischemic Heart Disease; Stable angina; Fractional flow reserve; Index of Microcirculatory Resistance; Coronary Flow Reserve; Intravascular Imaging

Outcome Measures

Primary Outcomes (1)

• patient-oriented composite outcome

  a composite of all-cause death, MI, any repeat revascularization

  24 months

Secondary Outcomes (15)

• patient-oriented composite outcome

  12 months

• patient-oriented composite outcome

  60 months

• All-cause death

  24 months

• cardiac death

  24 months

• Target-vessel nonfatal MI

  24 months

Study Arms (2)

Overt microvascular disease

Fractional flow reserve\>0.80, coronary flow reserve\<2 \& Index of microvascular resistance\>25U

Device: Comprehensive physiologic evaluation; Device: Intravascular imaging devices

No Overt microvascular disease

Fractional flow reserve\>0.80, coronary flow reserve\>2 \& Index of microvascular resistance\<25U

Device: Comprehensive physiologic evaluation; Device: Intravascular imaging devices

Interventions

Comprehensive physiologic evaluation DEVICE

Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance

Also known as: Comprehensive physiologic evaluation using pressure-temperature sensor wire

No Overt microvascular disease; Overt microvascular disease

Intravascular imaging devices DEVICE

Intravascular ultrasound or optical coherence tomography

Also known as: Intravascular ultrasound or optical coherence tomography

No Overt microvascular disease; Overt microvascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Seoul National University Hospital: collaborator
• Inje University Ilsan Paik Hospital: collaborator
• Ulsan University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (4)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia; Angina, Stable

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 25, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (4)