Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT03030495
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03030495
Study Brief:
Protocol Section:
NCT03030495