Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002920

Enrollment

1700

Registered

2018-06-07

Start date

2017-11-17

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral : post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing : routine stress testing vs. symptom oriented stress testing In the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject was > 19 years of age. Subjects who underwent successful PCI with contemporary drug eluting stent or contemporary bioresorbable vascular scaffold. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors. 3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI). 3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (= 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length =30 mm or stent length =32 mm), or vein bypass graft stented The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

Exclusion criteria: Cardiogenic shock at the index admission Subject treated with only bare metal stent or balloon angioplasty during the index procedure. Pregnant and/or lactating women. Concurrent medical condition with a life expectancy of less than 1 years Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 6 Subject was unable to provide written informed consent or participate in long-term follow-up.

Design outcomes

Primary

Measure	Time frame
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina	—

Secondary

Measure	Time frame
Myocardial infarction;Unstable angina hospitalization;Death or Myocardial infarction;Any hospitalization;Invasive catheterization;Repeat revascularization procedure	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-jung Park

University of Ulsan

sjpark@amc.seoul.kr+82-2-3010-4812

Outcome results