Reduction of PCI time in STEMI

JRCT ID: jRCTs032220243

Registered date:04/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: ST elevated myocardial infarction
• Date of first enrollment: 07/11/2022
• Target sample size: 430
• 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

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
• 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
• Source(s) of Monetary Support: Boston Scientific Japan K.K.