Coronary Artery Disease
Conditions
Keywords
follow-up coronary angiography
Brief summary
The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.
Detailed description
Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.
Interventions
PROCEDUREfollow-up coronary angiography
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
PROCEDUREClinical follow-up
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Sponsors
Takeshi Morimoto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients received percutaneous coronary intervention * Patients older than 20 years old * Patients who will not scheduled any staged percutaneous coronary intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure | 4.8 years | a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiac death | 4.8 years | cardiac death |
| myocardial infarction | 4.8 years | myocardial infarction |
| stent thrombosis | 4.8 years | stent thrombosis defined bya Academic Reseach Consortium |
| stroke | 4.8 years | both ischemic and hemorrhagic stroke excluding transient ischemic attach |
| bleeding complications | 4.8 years | bleeding complications defined by GUSTO and TIMI |
| any coronary revascularization | 4.8 years | any coronary revascularization |
| clinically-driven coronary revascularization | 4.8 years | clinically-driven coronary revascularization |
| clinically-driven target-lesion revascularization | 4.8 years | clinically-driven target-lesion revascularization |
| death | 4.8 years | death |
| coronary artery bypass grafting | 4.8 years | coronary artery bypass grafting |
| angina | 4.8 years | angina |
| renal function | 4.8 years | estimate-glomerular filtration rate |
| emergency hospitalization for acute coronary syndrome | 4.8 years | emergency hospitalization for acute coronary syndrome |
| hospitalization for congestive heart failure | 4.8 years | hospitalization for congestive heart failure |
| composite of cardiac death, myocardial infarction or acute coronary syndrome | 4.8 years | composite of cardiac death, myocardial infarction or acute coronary syndrome |
| follow-up coronary angiography | 4.8 years | presence of follow-up coronary angiography |
| clinically-driven follow-up coronary angiography | 4.8 years | presence of clinically-driven follow-up coronary angiography |
| any target-lesion revascularization | 4.8 years | any target-lesion revascularization |
Countries
Japan
Outcome results
None listed