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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: traditional approach; Procedure: culprit vessel intervention

• Registration Number: NCT03272451
• Lead Sponsor: Beijing Luhe Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional approach	traditional approach	complete coronary angiography followed by guiding catheter selection for culprit vessel PCI
culprit vessel intervention	culprit vessel intervention	culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Luhe hospital; 🇨🇳 Beijing, China