NCT06745141招募中不适用
Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in ejection fraction
研究概览
简要总结
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:
- •5 teeth with clinical attachment loss (CAL) ≥ 4 mm.
- •Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.
排除标准
- •under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth < 8); 4) long hospital stay (>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
结局指标
主要结局
Changes in ejection fraction
时间窗: From enrollment to the end of treatment at 6 months
The ejection fraction (EF) changed by 10% half a year after surgery
次要结局
- Cardiovascular death and MACE events were recorded(From enrollment to the end of treatment at 6 months, a maximum of 12 months.)
- level of proBNP(From enrollment to the end of treatment at 6 months)
研究者
Ya-Wei Xu
professor of medicine
Shanghai 10th People's Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Chairside Mouthrinse Test and Cost EffectivenessPeriodontitis, JuvenileNCT04139863University of Helsinki200
已完成
不适用
Oral Health Intervention Pilot Study for Individuals With Memory ProblemsMild Cognitive ImpairmentNCT01808235Duke University12
招募中
不适用
MOLAR: Mapping Oral Health and Local Area ResourcesDental DiseasesNCT05688982Massachusetts General Hospital2,927
已完成
不适用
Oral Health Promotion Mediated by Teledentistry in Community-dwelling Older Adults of La Araucanía Region, ChileOral Health KnowledgeOral Health AttitudesOral Health Self-efficacyNCT05917548Fernanda Muñoz Sepúlveda117
进行中（未招募）
不适用
Natural History Study in Pediatric Patients With MYBPC3 Mutation-associated CardiomyopathyCardiomyopathyNCT05112237Tenaya Therapeutics200