Unstable Angina Clinical Trial
Official title:
International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain
Verified date | September 2018 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).
Status | Completed |
Enrollment | 1397 |
Est. completion date | September 26, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery Exclusion Criteria: - Patients with hemodynamic instability - left ventricular dysfunction - culprit vessel of acute coronary syndrome |
Country | Name | City | State |
---|---|---|---|
Japan | Tokyo Medical and Dental University | Tokyo | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Spain | Hospital Clinico San Carlos, Madrid, Spain | Madrid |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Hospital San Carlos, Madrid, Imperial College Healthcare NHS Trust, Inje University, Keimyung University Dongsan Medical Center, Samsung Medical Center, Sungkyunkwan University, Tokyo Medical and Dental University, Tsuchiura Kyodo General Hospital, Ulsan University Hospital |
Japan, Korea, Republic of, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization | Patient-oriented composite outcome | 5 year | |
Primary | Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization | Vessel-oriented composite outcome | 5 year | |
Secondary | Cumulative incidence of any death | all-cause mortality | 5 year | |
Secondary | Cumulative incidence of cardiac death | cardiac death | 5 year | |
Secondary | Cumulative incidence of myocardial infarction | MI was defined as elevated cardiac enzyme levels greater than the upper limit of the normal range with either ischemic symptoms or electrocardiography changes indicating ischemia after index procedure. Periprocedural MI was not included as a clinical outcome | 5 year | |
Secondary | Cumulative incidence of ischemia-driven revascularization | Ischemia-driven revascularization was defined as a revascularization procedure with at least one of the following: (1) recurrence of angina; (2) positive non-invasive test; and (3) positive invasive physiologic test | 5 year |
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