JRCT ID: jRCTs032220243
Registered date:04/08/2022
Reduction of PCI time in STEMI
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | ST elevated myocardial infarction |
Date of first enrollment | 07/11/2022 |
Target sample size | 430 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | The first catheter is randomly assigned to a diagnostic catheter or a Ikari curve guiding catheter in primary PCI. |
Outcome(s)
Primary Outcome | Sheath-to-First device activation time |
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Secondary Outcome | 1)Door-to-balloon time 2)Total ischemic time 3)Fluorescence dose and time 4)Contrast dye volume 5)Total number of catheters 6)Cost of total admission 7)All-cause and cardiovascular-cause mortality at 30 days 8)Bleeding complications at 30 days 9)Factors relating with the primary endpoint 10)All-cause and cardiovascular-cause mortality at 1 year 11) Success rate of single catheter PCI (SC-PCI) method 12) Analysis of primary and secondary endpoints by facility |
Key inclusion & exclusion criteria
Age minimum | >= 21age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients with ST elevation myocardial infarction for whom primary PCI is indicated. |
Exclude criteria | 1)Cardiogenic shock cases that require insertion of Impella, ECMO or IABP prior to PCI 2)Cardiac arrest cases that require cardiac resuscitation 3)Bradycardia requiring temporary pacemaker 4)Renal failure on maintenance dialysis 5)Cases deemed inappropriate for registration |
Related Information
Primary Sponsor | Torii Sho |
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Secondary Sponsor | |
Source(s) of Monetary Support | Boston Scientific Japan K.K. |
Secondary ID(s) |
Contact
Public contact | |
Name | Yuji Ikari |
Address | 143 SHIMOKASUYA, ISEHARA KANAGAWA, 259-1193 JAPAN Kanagawa Japan 259-1193 |
Telephone | +81-463-93-1121 |
ikari@tokai.ac.jp | |
Affiliation | Tokai University Hospital |
Scientific contact | |
Name | Sho Torii |
Address | 143 SHIMOKASUYA, ISEHARA KANAGAWA, 259-1193 JAPAN Kanagawa Japan 259-1193 |
Telephone | +81-463-93-1121 |
ts2877@tokai.ac.jp | |
Affiliation | Tokai University Hospital |