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Post-DES FFR predicts the clinical outcomes: DK CRUSH-VII, A Prospective, Multicenter, Registry Study
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注册号:

Registration number:

ChiCTR-PRCH-12001976 

最近更新日期:

Date of Last Refreshed on:

2015-08-03 

注册时间:

Date of Registration:

2012-02-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

冠状动脉药物洗脱支架术后即刻血流储备分数与临床预后间关系的前瞻性、多中心、注册研究 

Public title:

Post-DES FFR predicts the clinical outcomes: DK CRUSH-VII, A Prospective, Multicenter, Registry Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

冠状动脉药物洗脱支架术后即刻血流储备分数与临床预后间关系的前瞻性、多中心、注册研究 

Scientific title:

Post-DES FFR predicts the clinical outcomes: DK CRUSH-VII, A Prospective, Multicenter, Registry Study 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

阚静 

研究负责人:

陈绍良 

Applicant:

Jing Kan 

Study leader:

Shaoliang Chen 

申请注册联系人电话:

Applicant telephone:

+86 025 5227 1398 

研究负责人电话:

Study leader's telephone:

+86 025 5227 1351 

申请注册联系人传真 :

Applicant Fax:

+86 025 5220 8048 

研究负责人传真:

Study leader's fax:

+86 025 5220 8048 

申请注册联系人电子邮件:

Applicant E-mail:

kanjingok@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chmengx@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

长乐路68号,南京,中国 

研究负责人通讯地址:

长乐路68号,南京,中国 

Applicant address:

68 Changle Road, Nanjing, China 

Study leader's address:

68 Changle Road, Nanjing, China 

申请注册联系人邮政编码:

Applicant postcode:

210006 

研究负责人邮政编码:

Study leader's postcode:

210006 

申请人所在单位:

南京医科大学附属南京第一医院 

Applicant's institution:

Nanjing First Hospital, Nanjing Medical Univeristy 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

20120316-1 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京市第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Nanjing First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-16 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

南京医科大学附属南京第一医院 

Primary sponsor:

Nanjing First Hospital, Nanjing Medical Univeristy 

研究实施负责(组长)单位地址:

长乐路68号,南京,中国 

Primary sponsor's address:

68 Changle Road, Nanjing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

南京医科大学第一附属医院

具体地址:

长乐路68号,南京,中国

Institution
hospital:

Nanjing First Hospital, Nanjing Medical Univeristy

Address:

68 Changle Road, Nanjing, China

经费或物资来源:

江苏省科技进步奖 

Source(s) of funding:

Jiangsu Provincial Medical Outstanding Program 

研究疾病:

冠状动脉粥样硬化性心脏病 

Target disease:

Coronary artery disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察冠状动脉药物洗脱支架术后即刻血流储备分数达标率,以及冠状动脉药物洗脱支架术后即刻血流储备分数与1年和2年临床随访主要不良心脏事件关系的前瞻性、多中心、注册研究。 

Objectives of Study:

In a prospective, multicenter, 2-year follow-up registry study to Observation of Post-DES FFR and clinical outcomes in patients with coronary disease using drug-eluting stent (DES). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)受试者年龄18-80岁 2)受试者(或法定监护人)理解试验要求和治疗程序,在执行任何方案规定的检查或操作前,签署了书面知情同意书 3)适合经皮冠状动脉介入治疗 4)稳定性心绞痛或不稳定性心绞痛受试者 5)从胸痛发作到诊断为急性心肌梗死超过 24小时的受试者的非梗死相关血管 6)可接受冠状动脉搭桥术 7)自愿接受方案要求的所有随访评估 

Inclusion criteria

1. subjects aged 18-80 years old; 2. subjects (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; 3. subjects is eligible for percutaneous coronary intervention (PCI); 4. subjects has Stable/unstable angina; 5. Non-infarct-related artery of subjects has STEMI>24-hour from the onset of chest pain to admission; 6. subjects is an acceptable candidate for coronary artery bypass grafting (CABG); 7. subjects is willing to comply with all protocol-required follow-up evaluations. 

排除标准:

1)急性心肌梗死相关血管 2)受试者患有心房纤颤 3)受试者对研究支架系统或方案要求的伴随药物过敏(如西罗莫司、噻吩并吡啶或阿司匹林;造影剂;丙烯酸;不锈钢) 4)患有其他预期寿命小于12个月的严重的疾病(如癌症等) 5)孕妇 6)正在参加另一项试验药物或器械的临床试验还未达到主要终点,或计划在术后12个月内参加另一项实验性药物或器械的临床试验 7)左主干病变 8)严重钙化需要旋磨治疗 9)桥血管病变 

Exclusion criteria:

1. Subjects with STEMI (within 24-hour from the onset of chest pain to admission); 2. Subjects suffering from atrial fibrillation; 3. Subjects has known allergy to the study stent system (everolimus) or protocol-required concomitant medications; 4. Subjects has any other serious medical illness that may reduce life expectancy to less than 12 months; 5. Subjects is a women who is pregnant or nursing; 6. Subjects has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure; 7. Left main disease; 8. Severe calcification need Rotablator treatment; 9. Bridge vessels of coronary artery bypass graft (CABG). 

研究实施时间:

Study execute time:

From2012-05-01To 2013-05-01 

干预措施:

Interventions:

组别:

FFR达标(FFR≥0.8)组

样本量:

120

Group:

Group 1

Sample size:

干预措施:

测量术后即刻FFR

干预措施代码:

Intervention:

FFR reach the standard

Intervention code:

组别:

FFR不达标(FFR<0.8)组

样本量:

120

Group:

Group 2

Sample size:

干预措施:

测量术后即刻FFR

干预措施代码:

Intervention:

FFR not reach the standard

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

江苏 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京医科大学附属南京第一医院 

单位级别:

三甲医院 

Institution
hospital:

Nanjing First Hospital, Nanjing Medical Univeristy  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血流储备分数

指标类型:

主要指标 

Outcome:

Fractional flow reservation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究为前瞻性队列研究,顺序入选,无随机

Randomization Procedure (please state who generates the random number sequence and by what method):

It is not randomization for the prospective cohort study.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-02-21
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