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Single Catheter Primary Percutaneous Coronary Intervention Method in Patients With ST Elevation Myocardial Infarction (SPEEDYPCI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Tokai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Primary percutaneous coronary intervention, Door-to-balloon time, guiding catheter

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age of 21 years or older Acute ST-segment elevation myocardial infarction Patients indicated for Primary PCI within 12 hours after onset Exclusion Criteria: Patients with shock requiring insertion of Impella, ECMO or IABP before PCI Patients requiring cardiopulmonary resuscitation due to cardiac arrest Patients requiring temporary pacemaker due to bradycardia Patients undergoing dialysis Patients judged by the attending physician to be inappropriate for registration

Sites / Locations

  • Tokai University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SC-PCI

Conventional

Arm Description

Primary PCI is initiated with a universal guiding catheter (Ikari left). The guiding catheter is used to contrast the left and right coronary arteries and PCI is started directly. This method does not require a catheter exchange. It is Single Catheter PCI (SC-PCI) method.

Primary PCI is initiated with a diagnostic catheter. The catheter is used to contrast one of the coronary arteries. Then, the catheter is replaced with a contralateral side diagnostic catheter. Then, the catheter is replaced with a guiding catheter and PCI is started.

Outcomes

Primary Outcome Measures

Sheath-to-first device activation time
Time from insertion of sheath to reperfusion treatment apparatus (First device activation)

Secondary Outcome Measures

Door-to-balloon time
Time from arrival at hospital to reperfusion treatment apparatus (First device activation)
Total ischemia time
Time from the onset of myocardial infarction to achievement of TIMI 3 reperfusion
Fluoroscopy time and fluoroscopy dose
Radiation dose assessed as fluoroscopy time and dose
Amount of contrast medium
Dose of contrast medium used during PCI procedure
Number of catheters used
Total number of catheters used during the PCI procedure
Hospital expense
Total cost required for the total hospital stay
All-cause mortality and cardiovascular mortality at 30 days
All-cause mortality and cardiovascular mortality at 30 days
Hemorrhagic complication rate at 30 days
BARC 3 or 5 hemorrhagic complications
All-cause mortality and cardiovascular mortality at 1 year
All-cause mortality and cardiovascular mortality at 1 year
Success rate of SC-PCI method
Success of SC-PCI method is defined as diagnostic angiography and PCI is performed using a single universal guiding catheter, Ikari left.

Full Information

First Posted
October 9, 2022
Last Updated
November 21, 2022
Sponsor
Tokai University
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05604976
Brief Title
Single Catheter Primary Percutaneous Coronary Intervention Method in Patients With ST Elevation Myocardial Infarction
Acronym
SPEEDYPCI
Official Title
To Investigate Whether Single Catheter Primary PCI Method Can Reduce the Time Required for Primary PCI in Cases of ST Elevation Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokai University
Collaborators
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to test reducing procedure time of percutaneous coronary intervention (PCI) in ST elevation myocardial infarction by single catheter PCI (SC-PCI) method. The main question it aims to answer is: • [question 1] SC-PCI method is skipping catheter exchange with use of a right and left dual purpose universal guiding catheter Ikari Left curve. Does SC-PCI method reduce PCI procedure time? Participants will be randomly assigned to SC-PCI method or conventional method and emergency PCI is performed. Researchers will compare time from sheath insertion to first device activation between the SC-PCI method and the conventional method.
Detailed Description
<<Background>> Acute ST-segment elevation myocardial infarction is a disease of high acute-phase mortality rate, but the life can be saved by implementing emergency percutaneous coronary intervention (PCI). Its efficacy is higher than that of thrombolytic therapy. Moreover, shortening of total ischemia time reduces the mortality rate and can promote recovery of cardiac function. The total ischemia time can be classified into the time from onset to arrival at hospital and the time from arrival at hospital to recanalization of coronary artery (Door-to-balloon time), and shortening of time in all steps is recommended. Various methods, including the part of transportation to hospital and from arrival at hospital to treatment room, are proposed, but there is no effective method for shortening of procedure time for PCI. Since the right and left dual-purpose universal guiding catheter can be inserted into both the left and right coronary arteries, the time for replacement of catheter can be shortened. Since IKARI Curve catheter is considered to be the most excellent catheter as the universal guiding catheter, it is considered useful for shortening of reperfusion time in myocardial infarction. <<Objectives.>> There are a lot of reports that decreased mortality and improvement of cardiac function are observed by shortening of the time from onset of acute myocardial infarction to recanalization. However, shortening of catheterization time, a part of the time, has not been examined. In 60 patients in a single-center retrospective study performed in Tokai University, the time from arterial puncture to reperfusion was shortened, and the time from arrival at hospital to reperfusion was also shortened. In 1275 patients in a multi-center retrospective study, moreover, the time from arterial puncture to reperfusion was significantly shortened by 4 minutes, and a significant decrease was also observed in the time from arrival at hospital to reperfusion. The Door-to-balloon time at this time was 68±46 minutes in the SC-PCI group and 76±51 minutes by the conventional method. Moreover, the time from insertion of sheath to balloon was 19±14 minutes in the SC-PCI group and 23±14 minutes by the conventional method. In addition, shortening of fluoroscopy time was also observed. Based on this result, the information shall be collected from prospective multi-center randomized study and analyzed to verify that the right and left dual-purpose guiding catheter is useful for shortening of reperfusion time in myocardial infarction. <<Methods.>> Multi-center cooperative prospective interventional study, 2-group comparative study, and randomization <Conventional method> If the patients are allocated to this group, the procedure shall be started with an angiographic catheter. An angiographic catheter is a catheter classified into a special treatment material, "Angiographic Catheter (General Model) Request Code 738180000," and approved for insurance coverage. The catheters adopted by each institution shall be used. Coronary angiography shall be performed using an angiographic catheter, and PCI shall be performed by replacing to a guiding catheter. There are methods in which a catheter for angiography on right and left sides is performed, a dual-purpose contrast catheter is used, and one contrast catheter and guiding catheter are used, but any method is acceptable if the procedure is started from an angiographic catheter. <SC-PCI method> When allocated to this group, the procedure shall be started with a guiding catheter of Ikari L Curve. As the Ikari L Curves approved for insurance coverage in Japan, 52 types exist by catalogue according to the difference in diameter and form, of 6 shafts of 5 companies (attached documents). Any of them shall be used. Thereafter, the right and left coronary angiography shall be performed with one right and left dual-purpose guiding catheter, and then PCI shall be performed. Even if allocated to any group, Synergy stent shall be used when a stent is placed in coronary artery dilation. A prospective randomization study shall be performed to reduce the bias. For the Sheath-to-First device activation time, a primary endpoint, a test of superiority shall be performed. For the Door-to-balloon time, a secondary endpoint, a test of non-inferiority shall be performed, and if the non-inferiority is demonstrated, a test of superiority shall also be performed. The primary endpoint shall be analyzed by Intention-to-treat. The operators who can participate in this study shall take charge of any group, and who are the PCI operators who have used the Ikari L Curve guiding catheter on the right coronary artery in at least 5 patients and left coronary artery in at least 5 patients. <<Number of Target Patients and Rationales for Setting>> <Number of target patients> 400 patients in total (200 patients for SC-PCI method, 200 patients for conventional method) <Rationale for setting> In a multicenter retrospective study, the time from insertion of sheath to balloon (S2B) was 19±14 minutes in the SC-PCI group and 23±14 minutes for the conventional method. When testing at the level of significance of 0.05 and the power of 0.8 based on this value, the number of patients will become 388. Considering 3% dropout cases, registration of a total of 400 patients is planned. A secondary endpoint, the D2B time was 68±46 minutes in the SC-PCI group and 76±51 minutes for the conventional method as a result of retrospective study. When testing at the level of significance of 0.05 and the power of 0.8 based on this value, the number of patients will become 1160. Therefore, the power is insufficient to show significance in the analysis of D2B time, and a non-inferiority test shall be performed. The margin of noninferiority is set at 1.3. If the D2B time by the conventional method is 76 minutes, the 1.3 times longer time is 98.8 minutes, and the difference is 22.8 minutes. In the treatment of myocardial infarction, the difference of 23 minutes or more is considered to be inferior from the standpoint of expert, and therefore it was set. Non-inferiority test shall be performed based on the 95% confidence interval (test of two-sided 5% or one-sided 2.5%) of the difference from mean value. If non-inferiority is shown, the test of superiority shall also be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Primary percutaneous coronary intervention, Door-to-balloon time, guiding catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants are randomly divided into two groups: one in which Primary PCI is initiated with a universal guiding catheter and the other with a diagnostic catheter. Compare time from sheath insertion to first device activation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC-PCI
Arm Type
Experimental
Arm Description
Primary PCI is initiated with a universal guiding catheter (Ikari left). The guiding catheter is used to contrast the left and right coronary arteries and PCI is started directly. This method does not require a catheter exchange. It is Single Catheter PCI (SC-PCI) method.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Primary PCI is initiated with a diagnostic catheter. The catheter is used to contrast one of the coronary arteries. Then, the catheter is replaced with a contralateral side diagnostic catheter. Then, the catheter is replaced with a guiding catheter and PCI is started.
Intervention Type
Device
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
Primary PCI for ST elevation myocardial infarction initiating with a universal guiding catheter or an angiographic catheter
Primary Outcome Measure Information:
Title
Sheath-to-first device activation time
Description
Time from insertion of sheath to reperfusion treatment apparatus (First device activation)
Time Frame
the end of PCI
Secondary Outcome Measure Information:
Title
Door-to-balloon time
Description
Time from arrival at hospital to reperfusion treatment apparatus (First device activation)
Time Frame
the end of PCI
Title
Total ischemia time
Description
Time from the onset of myocardial infarction to achievement of TIMI 3 reperfusion
Time Frame
the end of PCI
Title
Fluoroscopy time and fluoroscopy dose
Description
Radiation dose assessed as fluoroscopy time and dose
Time Frame
the end of PCI
Title
Amount of contrast medium
Description
Dose of contrast medium used during PCI procedure
Time Frame
the end of PCI
Title
Number of catheters used
Description
Total number of catheters used during the PCI procedure
Time Frame
the end of PCI
Title
Hospital expense
Description
Total cost required for the total hospital stay
Time Frame
30 days
Title
All-cause mortality and cardiovascular mortality at 30 days
Description
All-cause mortality and cardiovascular mortality at 30 days
Time Frame
At 30 days from the onset of STEMI
Title
Hemorrhagic complication rate at 30 days
Description
BARC 3 or 5 hemorrhagic complications
Time Frame
At 30 days from the onset of STEMI
Title
All-cause mortality and cardiovascular mortality at 1 year
Description
All-cause mortality and cardiovascular mortality at 1 year
Time Frame
1 year after the randomization
Title
Success rate of SC-PCI method
Description
Success of SC-PCI method is defined as diagnostic angiography and PCI is performed using a single universal guiding catheter, Ikari left.
Time Frame
the end of PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 21 years or older Acute ST-segment elevation myocardial infarction Patients indicated for Primary PCI within 12 hours after onset Exclusion Criteria: Patients with shock requiring insertion of Impella, ECMO or IABP before PCI Patients requiring cardiopulmonary resuscitation due to cardiac arrest Patients requiring temporary pacemaker due to bradycardia Patients undergoing dialysis Patients judged by the attending physician to be inappropriate for registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sho Torii, MD
Organizational Affiliation
Tokai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to obtain IPD consent from patients.
Citations:
PubMed Identifier
34057275
Citation
Lee KH, Torii S, Oguri M, Miyaji T, Kiyooka T, Ono Y, Asada K, Adachi T, Takahashi A, Ikari Y. Reduction of door-to-balloon time in patients with ST-elevation myocardial infarction by single-catheter primary percutaneous coronary intervention method. Catheter Cardiovasc Interv. 2022 Feb;99(2):314-321. doi: 10.1002/ccd.29797. Epub 2021 May 31.
Results Reference
result
PubMed Identifier
27125428
Citation
Torii S, Fujii T, Murakami T, Nakazawa G, Ijichi T, Nakano M, Ohno Y, Shinozaki N, Yoshimachi F, Ikari Y. Impact of a single universal guiding catheter on door-to-balloon time in primary transradial coronary intervention for ST segment elevation myocardial infarction. Cardiovasc Interv Ther. 2017 Apr;32(2):114-119. doi: 10.1007/s12928-016-0395-z. Epub 2016 Apr 28.
Results Reference
result
PubMed Identifier
19736091
Citation
Youssef AA, Hsieh YK, Cheng CI, Wu CJ. A single transradial guiding catheter for right and left coronary angiography and intervention. EuroIntervention. 2008 Jan;3(4):475-81. doi: 10.4244/eijv3i4a85.
Results Reference
result
PubMed Identifier
19901410
Citation
Ikari Y, Masuda N, Matsukage T, Ogata N, Nakazawa G, Tanabe T, Morino Y. Backup force of guiding catheters for the right coronary artery in transfemoral and transradial interventions. J Invasive Cardiol. 2009 Nov;21(11):570-4.
Results Reference
result
PubMed Identifier
16327043
Citation
Ikari Y, Nagaoka M, Kim JY, Morino Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and transradial interventions. J Invasive Cardiol. 2005 Dec;17(12):636-41.
Results Reference
result
PubMed Identifier
14760193
Citation
Ikari Y, Nakajima H, Iijima R, Aoki J, Tanabe K, Nakayama T, Miyazawa A, Hatori M, Kyouno H, Tanimoto S, Amiya E, Nakazawa G, Onuma Y, Hara K. Initial characterization of Ikari Guide catheter for transradial coronary intervention. J Invasive Cardiol. 2004 Feb;16(2):65-8.
Results Reference
result
PubMed Identifier
9637453
Citation
Ikari Y, Ochiai M, Hangaishi M, Ohno M, Taguchi J, Hara K, Isshiki T, Tamura T, Yamaguchi T. Novel guide catheter for left coronary intervention via a right upper limb approach. Cathet Cardiovasc Diagn. 1998 Jun;44(2):244-7. doi: 10.1002/(sici)1097-0304(199806)44:23.0.co;2-l.
Results Reference
result
Links:
URL
https://ikaricurve.com
Description
Homepage about Ikari curve

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Single Catheter Primary Percutaneous Coronary Intervention Method in Patients With ST Elevation Myocardial Infarction

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