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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272451
• Other study ID #: BeijingLH
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2022
• Source: Beijing Luhe Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: July 31, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• culprit vessel intervention
ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
• traditional approach
single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI

Locations

Country	Name	City	State
China	Beijing Luhe hospital	Beijing
China	Beijing Luhe hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MACE	major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR)	12 month
Primary	door to device (D2D) time	time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use	24hours
Secondary	puncture to device (P2D) time	time from radail artery puncture to first device(balloon,aspiration catheter or stent) use	24hours
Secondary	first medical contact to device (FMC2D) time	time from first medical contact to first device (balloon,aspiration catheter or stent) use.	24hours
Secondary	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)
Secondary	incidence of radial artery occlusion	the absence of palpable radial artery pulsation confirmed by echocardiogram	inhospital (an expected average of 5 days),30day,12month
Secondary	fluoroscopy time	recorded on the machine	1 hour
Secondary	cumulative air kerma(CAK) and dose area product(DAP).	recorded on the machine	1 hour