UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049578 |
|---|---|
| Receipt number | R000056465 |
| Scientific Title | Single Catheter Primary Percutaneous Coronary Intervention Method in Patients with ST Elevation Myocardial Infarction |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2025/11/25 19:20:55 |
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Basic information
Public title
Time reduction by single catheter PCI method for patients with acute myocardial infarction
Acronym
Speedy PCI
Scientific Title
Single Catheter Primary Percutaneous Coronary Intervention Method in Patients with ST Elevation Myocardial Infarction
Scientific Title:Acronym
Speedy PCI
Region
| Japan |
Condition
Condition
ST elevation myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Sheath-to-first device activation time
Time from insertion of sheath to reperfusion treatment apparatus (First device activation)
Key secondary outcomes
*Door-to-balloon time
*Total ischemia time
* Fluoroscopy time and fluoroscopy dose
* Amount of contrast medium
* Number of catheters used
* Hospital expense
* All-cause mortality and cardiovascular mortality at 30 days
* Hemorrhagic complication rate at 30 days
* All-cause mortality and cardiovascular mortality at 1 year
* Success rate of SC-PCI method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SC-PCI Method
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.
Interventions/Control_2
Conventional 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age of 21 years or older
Acute ST-segment elevation myocardial infarction
Patients indicated for Primary PCI within 12 hours after onset
Key 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
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Torii |
Organization
Tokai University
Division name
Cardiology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
ts2877@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Ikari |
Organization
Tokai University
Division name
Cardiology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
ikari@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center at Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rec@tokai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT05604976
Org. issuing International ID_1
Clinicaltrials.gov
Study ID_2
jRCTs 03220243
Org. issuing International ID_2
Japan Registry of Clinical Trials
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40624242/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40624242/
Number of participants that the trial has enrolled
430
Results
The SC-PCI method using the Ikari curve demonstrated a significant reduction in PCI procedure time while maintaining safety and procedural success in primary PCI for STEMI.
Results date posted
| 2025 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics were well balanced between the 2 groups, except for higher heart rate at admission in the SC-PCI method compared with the C-PCI method. The mean age was 69 +/-13 years, and 81.6% of patients were men. As the study was conducted during the COVID-19 era (November 2022 to October 2023), there was variability between facilities in handling patients upon arrival at the hospital. Most facilities began primary PCI after submitting an antigen test and implementing infection control measures, without waiting for the antigen test results. However, some facilities performed chest CT scans to determine if patients had COVID-19 pneumonia, while others waited for the COVID-19 antigen test results before proceeding to the cath lab.
Participant flow
In total of 430 patients were enrolled and randomly assigned from 47 centers in Japan. The full analysis included 194 patients in the SC-PCI method and 186 patients in the C-PCI method, after excluding 20 patients from the SC-PCI method and 30 from the C-PCI method. The reasons for exclusion were patients with MINOCA, aortic dissection, pulmonary embolism, and those without an indication for primary PCI. Additionally, 16 patients (6 from the SC-PCI method and 11 from the C-PCI method) met exclusion criteria such as the need for a temporary pacemaker before PCI.
Adverse events
The follow-up completion rate was 100% at 30 days and 99.5% at 1 year. The secondary endpoints at 30 days follow-up included all-cause death, cardiac death, and hemorrhage were similar between both groups. BARC 3 or 5 bleeding at PCI puncture site was zero in both groups. Other endpoints such as recurrent MI, stroke at 30 days was also comparable. Prevalence of all-cause mortality, recurrent MI, stroke, and bleeding at 1 year follow-up was also similar between the 2 groups .
Outcome measures
S2B time, which is the primary endpoint of the study, was significantly shorter in the SC-PCI method compared to the C-PCI method with 3 minute reduction of S2B time (15.8 +/- 10.9 minutes vs. 18.7 +/- 10.6 minutes, respectively, p=0.007) (Figure 2A, 2B, Table 3). On the other hand, the other secondary endpoints including D2B time, onset to door time, total ischemic time was similar between the 2 groups. Fluoroscopic time and dose, as well as volume of contrast was also similar between the 2 groups. Success rate of the SC-PCI method was 91.2% defined as completing the whole primary PCI procedure using only IL guiding catheter(s), 88.1% defined as completing the whole primary PCI procedure using an only single IL guiding catheter, and 85.1% defined as completing the whole primary PCI procedure using an only single IL guiding catheter with final TIMI 3 flow.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 12 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056465
