Back to resultsECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
culprit vessel intervention
traditional approach
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Patient must be > 18 years of age
- Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI
- Symptoms ≥ 30 min and ≤12 hours
- Patient and treating interventional cardiologist agree for randomization
- Patient provides written informed consent
- Diagnostic and therapeutic intervention performed through transradial artery approach
- Palpable radial artery.
Exclusion Criteria:
- Concurrent participation in other investigational study
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL
- Absence of radial artery pulsation
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
- Uncontrolled hypertension
- Prior CABG surgery
- Fibrinolytic therapy for current MI treatment
- patient have a life expectancy of <180days
Sites / Locations
- Beijing Luhe hospital
- Beijing Luhe hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
culprit vessel intervention
traditional approach
Arm Description
culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter
complete coronary angiography followed by guiding catheter selection for culprit vessel PCI
Outcomes
Primary Outcome Measures
door to device (D2D) time
time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
Secondary Outcome Measures
puncture to device (P2D) time
time from radail artery puncture to first device(balloon,aspiration catheter or stent) use
first medical contact to device (FMC2D) time
time from first medical contact to first device (balloon,aspiration catheter or stent) use.
incidence of radial artery spasm
radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure
incidence of radial artery occlusion
the absence of palpable radial artery pulsation confirmed by echocardiogram
fluoroscopy time
recorded on the machine
cumulative air kerma(CAK) and dose area product(DAP).
recorded on the machine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03272451
Brief Title
ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time
Official Title
ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Luhe Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
culprit vessel intervention
Arm Type
Experimental
Arm Description
culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter
Arm Title
traditional approach
Arm Type
Active Comparator
Arm Description
complete coronary angiography followed by guiding catheter selection for culprit vessel PCI
Intervention Type
Procedure
Intervention Name(s)
culprit vessel intervention
Intervention Description
ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
Intervention Type
Procedure
Intervention Name(s)
traditional approach
Intervention Description
single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI
Primary Outcome Measure Information:
Title
door to device (D2D) time
Description
time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
Time Frame
24hours
Secondary Outcome Measure Information:
Title
puncture to device (P2D) time
Description
time from radail artery puncture to first device(balloon,aspiration catheter or stent) use
Time Frame
24hours
Title
first medical contact to device (FMC2D) time
Description
time from first medical contact to first device (balloon,aspiration catheter or stent) use.
Time Frame
24hours
Title
incidence of radial artery spasm
Description
radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure
Time Frame
during the procedure (time from the guide catheter inserted to guide catheter removed)
Title
incidence of radial artery occlusion
Description
the absence of palpable radial artery pulsation confirmed by echocardiogram
Time Frame
inhospital (an expected average of 5 days),30day,12month
Title
fluoroscopy time
Description
recorded on the machine
Time Frame
1 hour
Title
cumulative air kerma(CAK) and dose area product(DAP).
Description
recorded on the machine
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
MACE
Description
major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be > 18 years of age
Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI
Symptoms ≥ 30 min and ≤12 hours
Patient and treating interventional cardiologist agree for randomization
Patient provides written informed consent
Diagnostic and therapeutic intervention performed through transradial artery approach
Palpable radial artery.
Exclusion Criteria:
Concurrent participation in other investigational study
Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL
Absence of radial artery pulsation
Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
Uncontrolled hypertension
Prior CABG surgery
Fibrinolytic therapy for current MI treatment
patient have a life expectancy of <180days
Facility Information:
Facility Name
Beijing Luhe hospital
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Beijing Luhe hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36386357
Citation
Guo J, Wang G, Li Z, Liu Z, Wang Y, Wang S, Wang Y, Wu Y, Wang H, Wang Y, Zhang L, Hua Q. Culprit vessel revascularization first with primary use of a dedicated transradial guiding catheter to reduce door to balloon time in primary percutaneous coronary intervention. Front Cardiovasc Med. 2022 Oct 28;9:1022488. doi: 10.3389/fcvm.2022.1022488. eCollection 2022.
Results Reference
derived
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ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time
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