Evidence map›Paper›PMID 39587685›Full record

ArticleTrials2024

Intracoronary administration of tenecteplase to prevent PCI-related myocardial infarction in patients with echo-attenuated coronary plaques: study protocol for a multicenter, prospective, randomized controlled trial.

Xu-Lin Hong, Yi-Hao Loh, Duan-Bin Li, Yi Luan, Wen-Bin Zhang

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Xu-Lin Hong *Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yi-Hao Loh *Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Duan-Bin LiDepartment of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yi Luan *Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. ryan1218@zju.edu.cn.
Wen-Bin Zhang *Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. 3313011@zju.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPercutaneous coronary intervention (PCI)-related myocardial infarction (MI), especially the distal type associated with microvascular dysfunction, is not an uncommon complication of the procedure. Specific lesion features, the echo-attenuated plaques (EA) in particular, are well-established contributors to the pathogenesis of distal-type MI. These plaques are prone to disruption during PCI, leading to microvascular thrombosis and distal embolism. Tenecteplase (TNK), a 3rd-generation thrombolytic drug, has demonstrated effective thrombolytic capacity without significantly increasing the bleeding risk. Our study aims to evaluate whether a low-dose intracoronary TNK administration prior to PCI in patients with intravascular ultrasound (IVUS)-detected EA can reduce the occurrence of PCI-related MI and improve clinical outcomes.

methodsThis trial is designed as a multicenter, prospective randomized controlled trial with a 1-month follow-up. The primary outcome of the study is the incidence of PCI-related myocardial infarction (MI) occurring within 48 h after PCI, which serves as a valid surrogate endpoint for assessing the efficacy of tenecteplase-based PCI in preventing future major adverse cardiovascular events (MACE) in patients with EA (Bulluck, et. al, Eur Heart J 42:2630-42, 2021) {1b.1}. Secondary outcomes include the proportion of patients with elevated postoperative high-sensitivity cTnI exceeding 5, 10, 35, and 70 times of the normal baseline, incidence of coronary slow flow after stent implantation and post-dilation, frame count of angiographic flow after stent implantation and post-dilation, as well as the incidence of MACE during hospitalization and at the 1-month follow-up. DISCUSSION: This trial may demonstrate that an immediate intracoronary administration of low-dose TNK following PCI can effectively lower the incidence of PMI in patients with EA, while confirming the safety of this therapeutic approach.

trial registrationChinese Clinical Trial Registry ( ChiCTR2400084840 ). Registered on May 27, 2024.

Indexed as

Fibrinolytic AgentsMulticenter Studies as TopicMyocardial InfarctionPercutaneous Coronary InterventionRandomized Controlled Trials as TopicTenecteplaseUltrasonography, InterventionalAgedChinaCoronary Artery DiseaseHumansMaleMiddle AgedPlaque, AtheroscleroticProspective StudiesTime FactorsFibrinolytic AgentsTenecteplaseCoronary artery diseaseEcho-attenuated plaqueMajor adverse cardiovascular eventsPercutaneous coronary interventionPeri-procedural myocardial infarctionTenecteplase

Identifiers

PMID39587685
PMCPMC11587588

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.