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ATP敏感性钾离子通道开放剂干预原发性冠状动脉微血管病变的前瞻性随机双盲对照研究
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注册号:

Registration number:

ChiCTR1900022978 

最近更新日期:

Date of Last Refreshed on:

2019-05-06 

注册时间:

Date of Registration:

2019-05-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

ATP敏感性钾离子通道开放剂干预原发性冠状动脉微血管病变的前瞻性随机双盲对照研究 

Public title:

A prospective, randomized, double-blind, controlled study for ATP-sensitive potassium channel openers in the treatment of primary coronary microvascular disease. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ATP敏感性钾离子通道开放剂干预原发性冠状动脉微血管病变的前瞻性随机双盲对照研究 

Scientific title:

A prospective, randomized, double-blind, controlled study for ATP-sensitive potassium channel openers in the treatment of primary coronary microvascular disease. 

研究课题代号(代码):

Study subject ID:

BJ-2018-201 

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:

张慧平 

研究负责人:

张慧平 

Applicant:

Huiping Zhang 

Study leader:

Huiping Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13911879076 

研究负责人电话:

Study leader's telephone:

+86 13911879076 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

huipingzhang73@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huipingzhang73@163.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:

北京医院心内科 北京市东单大华路1号,邮编:100730 

研究负责人通讯地址:

北京医院心内科 北京市东单大华路1号,邮编:100730 

Applicant address:

1 Dahua Road, Dong Dan, Beijing, China 

Study leader's address:

1 Dahua Road, Dong Dan, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100730 

研究负责人邮政编码:

Study leader's postcode:

100730 

申请人所在单位:

北京医院 

Applicant's institution:

Beijing Hospital, National Center of Gerontology, No 1 DaHua Road, Dong Dan, Beijing 100730, China 

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:

2019BJYYEC-021-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

北京医院伦理委员会 

Name of the ethic committee:

Institutionnal Review Board of Beijing Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-18 

伦理委员会联系人:

刘伟 

Contact Name of the ethic committee:

Wei Liu 

伦理委员会联系地址:

北京医院 北京市东单大华路1号,邮编:100730 

Contact Address of the ethic committee:

Beijing Hospital, National Center of Gerontology, 1 Dahua Road, Dong Dan, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-85138105 

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:

北京医院 

Primary sponsor:

Beijing Hospital, National Center of Gerontology 

研究实施负责(组长)单位地址:

北京市东单大华路1号,邮编:100730 

Primary sponsor's address:

1 Dahua Road, Dong Dan, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京医院

具体地址:

北京市东单大华路1号,邮编:100730

Institution
hospital:

Beijing Hospital

Address:

1 Dahua Road, Dong Dan, Beijing, China

经费或物资来源:

北京医院临床研究121工程项目 

Source(s) of funding:

Beijing Hospital Clinical Research 121 Project 

研究疾病:

冠状动脉微循环疾病 

Target disease:

Coronary Microvascular Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

对确诊冠状动脉微血管病变的患者给予KATP(ATP敏感性钾离子)通道开放剂治疗,通过观察心肌核素显像显示的心肌灌注缺损范围变化的指标,评价KATP通道开放剂对冠状动脉微血管病变的影响 

Objectives of Study:

To evaluate the effect of KATP channel opener on coronary microvascular disease by observing the changes of myocardial perfusion defect on myocardial SPECT in patients with confirmed coronary microvascular disease treated with KATP channel opener. 

药物成份或治疗方案详述:

尼克地尔或安慰剂,双盲随机给予 

Description for medicine or protocol of treatment in detail:

Nicotidil or placebo, to be given in a double-blind, randomized way 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1). 年龄在18岁以上,75岁以下; (2). 研究对象为有典型劳力性心绞痛的患者; (3). 研究对象(或法定监护人)理解研究要求和治疗程序,并在进行特定检查或程序之前能够提供书面知情同意书; (4). 研究对象愿意遵守研究方案要求的临床和随访评估,包括同意且能耐受负荷心肌核素显像(运动或三磷酸腺苷负荷)、冠状动脉造影、冠脉血流储备或乙酰胆碱激发试验等检查。 

Inclusion criteria

(1) Aged 18 to 75 years old; (2) The subjects were patients with typical exertional angina pectoris; (3) The subject (or legal guardian) understands the research requirements and treatment procedures and can provide written informed consent before conducting a specific examination or procedure; (4) The participants were willing to follow up the clinical and follow-up evaluation required by the research program, including consent and tolerance to stress myocardial SPECT (exercise or ATP stress), coronary angiography, coronary flow reserve or acetylcholine provocation test. 

排除标准:

(1). 研究对象拟诊不稳定心绞痛或急性心肌梗死的患者; (2). 研究对象已接受器官移植或正在等待接受器官移植; (3). 手术前后30天内受试者正在接受或计划接受化疗; (4). 研究对象对碘对比剂、腺苷、乙酰胆碱或尼可地尔过敏; (5). 研究对象已知有以下情况(根据筛查时的评估): ①可能会将预期寿命缩减至小于24个月的其他严重疾病(如癌症、充血性心力衰竭); ②目前有药物滥用问题(如酒精、可卡因、海洛因等); ③计划接受可能会引起方案不依从或数据理解混淆的手术; (6). 研究对象正在接受长期(≥72小时)抗凝血治疗(如肝素、华法林),治疗急性冠脉综合征(ACS)以外的疾病; (7). 研究对象的全血细胞计数(CBC)在范围之外,研究医生确认具有临床意义; (8). 研究对象有明确或可疑肝脏疾病,包括有肝炎的实验室证据; (9). 研究对象正在接受透析或基线血清肌酐水平>2.0 mg/dL(177μmol/L); (10). 研究对象有出血倾向或凝血疾病史或拒绝输血; (11). 研究者有活动性胃溃疡或活动性胃肠出血; (12). 研究者正在参加其他研究药物或器械的临床研究,且未达到其主要终点; (13). 研究者为妊娠或哺乳期女性(育龄期女性在手术前7天内必须进行妊娠试验)。 

Exclusion criteria:

1. The subjects were suspected of unstable angina pectoris or acute myocardial infarction; 2. The subjects have received or are waiting for organ transplantation; 3. Within 30 days before and after the operation, the subjects were receiving or planning to receive chemotherapy; 4. The subjects were allergic to iodine contrast agent, adenosine, acetylcholine or nicorandil; 5. The subjects were known to have the following information (based on the evaluation at the time of screening): (1) Life expectancy may be reduced to other serious diseases (such as cancer, congestive heart failure) less than 24 months; (2) Current problems of drug abuse (e.g. alcohol, cocaine, heroin, etc.); (3) Planned acceptance may lead to non-compliance or confusion in data understanding; 6. The subjects were receiving long-term (> 72 hours) anticoagulation therapy (such as heparin and warfarin) for diseases other than acute coronary syndrome (ACS); 7. The whole blood cell count (CBC) of the subjects is beyond the scope, and it is of clinical significance confirmed by doctors; 8. The subjects had definite or suspected liver diseases, including laboratory evidence of hepatitis; 9. The subjects were undergoing dialysis or baseline serum creatinine levels > 2.0 mg/dL (177 mol/L); 10. The subjects tended to bleed or had a history of coagulation disease or refused blood transfusion; 11. The subjects had active gastric ulcer or active gastrointestinal bleeding; 12. The subjects are participating in clinical studies of other research drugs or devices, and have not reached their primary endpoint; 13. The subjects were pregnant or lactating women (women of childbearing age had to undergo pregnancy tests within 7 days before entering the procedure). 

研究实施时间:

Study execute time:

From2019-06-01To 2023-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

42

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

试验组

样本量:

42

Group:

Experiment group

Sample size:

干预措施:

尼可地尔

干预措施代码:

Intervention:

Nicorandil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

心肌灌注缺损的范围

指标类型:

主要指标 

Outcome:

Scope of myocardial perfusion defect

Type:

Primary indicator 

测量时间点:

入组前及6个月后

测量方法:

心肌核素显像

Measure time point of outcome:

Before and 6 months after admission

Measure method:

Myocardial SPECT scanning

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

按1:1的比例进行盲法分组,对研究者和研究对象均设盲,研究结束后进行揭盲。用于药物随机编盲的随机数字表由统计学专业人员提供,利用SAS9.(或更高)软件固定种子数,并由与本次临床研究无关人员完成药物编盲及应急信件的准备工作,其中药物经随机编盲后的药物编号即为随机号。

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

SAS9. (or higher) software is used to generate allocation sequence.

盲法:

按1:1的比例进行盲法分组,对研究者和研究对象均设盲

Blinding:

Blind grouping was conducted according to the ratio of 1:1. Blindness was set for both researchers and research subjects.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

研究结束后,研究数据于伦理委员会储存、备索

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

At the end of the study, the data were stored and retrieved by the Ethics Committee.

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:

研究对象的资料将记录在电子数据采集系统中,所有临床数据的变化均可在审核记录中被追踪。数据库定期进行备份。研究将进行人工和/或电子数据审查,以确认可能的数据不一致之处。

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

The data of the subjects will be recorded in the electronic data acquisition system, and all changes in clinical data can be tracked in the audit records. The database is backed up regularly. The study will conduct manual and/or electronic data reviews to identify possible data inconsistencies.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-06
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