ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time

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

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).

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: culprit vessel intervention; Procedure: traditional approach

• Study Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Luhe hospital
  • Beijing, China, 101149
    • Beijing Luhe hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: culprit vessel intervention; culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter	Procedure: culprit vessel intervention; ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
Active Comparator: traditional approach; complete coronary angiography followed by guiding catheter selection for culprit vessel PCI	Procedure: traditional approach; single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
door to device (D2D) time	time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
puncture to device (P2D) time	time from radail artery puncture to first device(balloon,aspiration catheter or stent) use	24hours
first medical contact to device (FMC2D) time	time from first medical contact to first device (balloon,aspiration catheter or stent) use.	24hours
incidence of radial artery spasm	radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure	during the procedure (time from the guide catheter inserted to guide catheter removed)
incidence of radial artery occlusion	the absence of palpable radial artery pulsation confirmed by echocardiogram	inhospital (an expected average of 5 days),30day,12month
fluoroscopy time	recorded on the machine	1 hour
cumulative air kerma(CAK) and dose area product(DAP).	recorded on the machine	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)	12 month

Collaborators and Investigators

• Sponsor: Beijing Luhe Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: BeijingLH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No