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Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion (TFPCI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03788148
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Ho Choi, Samsung Medical Center

Brief Summary:
Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

Condition or disease Intervention/treatment
Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization Device: Stent, red blood cell transfusion

Detailed Description:

A Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.


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Study Type : Observational
Actual Enrollment : 28322 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Stent, red blood cell transfusion
    BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion


Primary Outcome Measures :
  1. Incidence density of MACE (Major adverse clinical events) [ Time Frame: 3 years ]
    The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.

  2. Incidence density of MACE (Major adverse clinical events) [ Time Frame: 1 year ]
    The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Korean patients undergoing BMS or DES implantation from January 1, 2005 to December 31, 2016 who received periprocedural red blood cell transfusion
Criteria

Inclusion Criteria:

  • Patients with percutaneous coronary intervention from 2006 to 2015
  • Patients with the implantation of BMS or DES
  • Patients with the receipt of periprocedural red blood cell transfusion

Exclusion Criteria:

  • Patients without any of stent implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788148


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jin-Ho Choi, MD, PhD Samsung Medical Center

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Responsible Party: Jin-Ho Choi, MD, PhD, Professor, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03788148     History of Changes
Other Study ID Numbers: SMC 2017-11-132
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Ho Choi, Samsung Medical Center:
transfusion, PCI, DES, BMS