SMC-PCI: Prospective Pecutaneous Coronary Intervention Registry

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05624905
Collaborator
(none)
15,000
1
177.4
84.6

Study Details

Study Description

Brief Summary

Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous coronary intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
15000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Registry for Identifying Long-term Prognosis in Patients Who Underwent Coronary Angiography and Percutaneous Coronary Intervention for Coronary Artery Disease
Actual Study Start Date :
Mar 20, 2016
Anticipated Primary Completion Date :
Dec 31, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
PCI group

All consecutive patients with coronary artery disease who underwent percutaneous coronary intervention

Procedure: Percutaneous coronary intervention
Percutaneous Coronary Intervention Procedure

Outcome Measures

Primary Outcome Measures

  1. Rates of Cardiac death or Target-vessel myocardial infarction [up to 10 years]

    A composite of cardiac death or target vessel myocardial infarction

  2. Rates of Major adverse cardiac and cerebrovascular event [up to 10 years]

    A composite of all-cause death, myocardial infarction, cerebrovascular accident, or repeat revascularization

Secondary Outcome Measures

  1. Rates of all-cause death [up to 10 years]

    Death from any cause

  2. Rates of cardiac death [up to 10 years]

    Death from cardiac cause

  3. Rates of myocardial infarction [up to 10 years]

    Any myocardial infarction

  4. Rates of target-vessel myocardial infarction [up to 10 years]

    target-vessel myocardial infarction

  5. Rates of target lesion revascularization [up to 10 years]

    target lesion revascularization

  6. Rates of target vessel revascularization [up to 10 years]

    target vessel revascularization

  7. Rates of cerebrovascular accident [up to 10 years]

    ischemic or hemorrhagic stroke

  8. Rates of stent thrombosis [up to 10 years]

    definite or probable stent thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.
Exclusion Criteria:
  • patients who did not consent to the research

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joo-Yong Hahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05624905
Other Study ID Numbers:
  • SMC-PCI
First Posted:
Nov 22, 2022
Last Update Posted:
Nov 22, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2022