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

NCT ID: NCT03272451

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2019-07-31

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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culprit vessel intervention

culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter

Group Type EXPERIMENTAL

culprit vessel intervention

Intervention Type PROCEDURE

ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5

traditional approach

complete coronary angiography followed by guiding catheter selection for culprit vessel PCI

Group Type ACTIVE_COMPARATOR

traditional approach

Intervention Type PROCEDURE

single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI

Interventions

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culprit vessel intervention

ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5

Intervention Type PROCEDURE

traditional approach

single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Luhe Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Luhe hospital

Beijing, , China

Site Status

Beijing Luhe hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36386357 (View on PubMed)

Other Identifiers

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BeijingLH

Identifier Type: -

Identifier Source: org_study_id

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