Clinical trial NCT03272451: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Beijing Luhe Hospital
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: door to device (D2D) time
timeFrame: 24hours
Secondary outcomes:
measure: puncture to device (P2D) time
timeFrame: 24hours
measure: first medical contact to device (FMC2D) time
timeFrame: 24hours
measure: incidence of radial artery spasm
timeFrame: during the procedure (time from the guide catheter inserted to guide catheter removed)
measure: incidence of radial artery occlusion
timeFrame: inhospital (an expected average of 5 days),30day,12month
measure: fluoroscopy time
timeFrame: 1 hour
measure: cumulative air kerma(CAK) and dose area product(DAP).
timeFrame: 1 hour
Other outcomes:
measure: MACE
timeFrame: 12 month
Locations:
city: Beijing
country: China
facility: Beijing Luhe hospital
city: Beijing
country: China
facility: Beijing Luhe hospital
Study officials:
References:
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.