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Dr.Nicolini Antonello, please upload 'Approved file of Ethical Committee' via chictr002@chictr.org.cn. RETINAL VEIN OCCLUSION IN PATIENTS WITH SLEEP OBSTRUCTIVE APNOEA
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注册号：

Registration number：

 ChiCTR2100054058 

最近更新日期：

Date of Last Refreshed on：

 2022-11-06 17:06:44 

注册时间：

Date of Registration：

 2021-12-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Dr.Nicolini Antonello, please upload 'Approved file of Ethical Committee' via chictr002@chictr.org.cn. RETINAL VEIN OCCLUSION IN PATIENTS WITH SLEEP OBSTRUCTIVE APNOEA

Public title：

RETINAL VEIN OCCLUSION IN PATIENTS WITH SLEEP OBSTRUCTIVE APNOEA

注册题目简写：

English Acronym：

研究课题的正式科学名称：

RETINAL VEIN OCCLUSION IN PATIENTS WITH SLEEP OBSTRUCTIVE APNOEA

Scientific title：

RETINAL VEIN OCCLUSION IN PATIENTS WITH SLEEP OBSTRUCTIVE APNOEA

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：

Nicolini Antonello 

研究负责人：

Nicolini Antonello 

Applicant：

Nicolini Antonello 

Study leader：

Nicolini Antonello 

申请注册联系人电话：

Applicant telephone：

 00393495952294

研究负责人电话：

Study leader's
telephone：

00393495952294

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：

 antonellonicolini@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 antonellonicolini@gmail.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：

Sestri Levante via Novara 5

研究负责人通讯地址：

Sestri Levante via Novara 5

Applicant address：

Sestri Levante via Novara 5

Study leader's address：

Sestri Levante via Novara 5

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

意大利米兰Don Gnocchi Foundation IRCCS Milan

Applicant's institution：

Don Gnocchi Foundation IRCCS milan

研究负责人所在单位：

意大利米兰Don Gnocchi Foundation IRCCS Milan

Affiliation of the Leader：

Don Gnocchi Foundation IRCCS milan

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：

 Reference 2018.2179

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：

Medical Investigations Ethics Committee (CEIM) of Cantabria

Name of the ethic committee：

Medical Investigations Ethics Committee (CEIM) of Cantabria

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-10-24 00:00:00

伦理委员会联系人：

Medical Investigations Ethics Committee (CEIM) of Cantabria

Contact Name of the ethic committee：

Medical Investigations Ethics Committee (CEIM) of Cantabria

伦理委员会联系地址：

Medical Investigations Ethics Committee (CEIM) of Cantabria

Contact Address of the ethic committee：

Medical Investigations Ethics Committee (CEIM) of Cantabria

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：

Sleep and Ventilation Unit. Pneumology Department. Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain

Primary sponsor：

Sleep and Ventilation Unit. Pneumology Department. Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain

研究实施负责（组长）单位地址：

Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain

Primary sponsor's address：

Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Spain

省(直辖市)：

Cantabria

市(区县)：

Country：

Spain

Province：

Cantabria

City：

santander

单位(医院)：

Department of Internal Medicine. Marqués de Valdecilla University Hospital. Cantabria University. IDIVAL. Santander. Spain.

具体地址：

santander

Institution
hospital：

Department of Internal Medicine. Marqués de Valdecilla University Hospital. Cantabria University. IDIVAL. Santander. Spain.

Address：

santander

经费或物资来源：

no funding

Source(s) of funding：

no funding

研究疾病：

osas  

Target disease：

osas

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

To study the relationship between both diseases, we analysed the cardiovascular risk profile and polygraphy aspects in a group of patients with OSA and RVO.  

Objectives of Study：

To study the relationship between both diseases, we analysed the cardiovascular risk profile and polygraphy aspects in a group of patients with OSA and RVO.

药物成份或治疗方案详述：

From a cohort of 408 patients diagnosed with RVO followed up for 12 yrs., we analysed those patients referred to the Sleep and Ventilation Unit of our hospital after clinical screening and who were diagnosed with OSA (n=21). We also included a control group of 21 patients with OSA, but without RVO, adjusted by age and gender from our hospital’s Sleep Unit Registry. The diagnosis of OSA was made according to the AASM criteria on a manual reading of a polygraph from the Philips Respironics Alice PDx diagnostic in all patients. The following variables were collected: total recording time in minutes, respiratory events such as obstructive, mixed and central total apnea/hypopnea index (AHI), mean oxyhemoglobin arterial saturation (SaO2), percentage of recording time with SaO2 < 90% (CT90: <30) and the desaturation index (ID: number of desaturations per hour of recording). RVO was diagnosed by ophthalmology based on clinical criteria, angiography and fundoscopy. The location of the RVO (central or peripheral), best corrected visual acuity (BCVA), initial and after one year, the presence of macular oedema, intravitreal treatment (antiangiogenics and dexamethasone implants) and the need for argon laser photo coagulation were recorded. The following clinical variables were recorded: age (yrs.), gender, weight (Kg), height (cm), BMI (Kg/m2), current smoker (yes, no or former > 2 yrs.), alcohol consumption (yes, no, former drinker >2 yrs.), arterial hypertension (AHT > 140-90 mm Hg), diabetes mellitus, hypercholesterolemia, statin use and glaucoma. At the time of the polygraphy, blood pressure readings and were measured total cholesterol (mg/dl), triglycerides (mg/dl), low-density lipoprotein cholesterol (LDL-c) mg/dl, high-density lipoprotein cholesterol (HDL-C) mg/dl, folic acid ng/ml and vitamin B12 pg/ml. Atherogenic index of plasma (LDL/HDL and total cholesterol/HDL-c) was determined.  

Description for medicine or protocol of treatment in detail：

From a cohort of 408 patients diagnosed with RVO followed up for 12 yrs., we analysed those patients referred to the Sleep and Ventilation Unit of our hospital after clinical screening and who were diagnosed with OSA (n=21). We also included a control group of 21 patients with OSA, but without RVO, adjusted by age and gender from our hospital’s Sleep Unit Registry. The diagnosis of OSA was made according to the AASM criteria on a manual reading of a polygraph from the Philips Respironics Alice PDx diagnostic in all patients. The following variables were collected: total recording time in minutes, respiratory events such as obstructive, mixed and central total apnea/hypopnea index (AHI), mean oxyhemoglobin arterial saturation (SaO2), percentage of recording time with SaO2 < 90% (CT90: <30) and the desaturation index (ID: number of desaturations per hour of recording). RVO was diagnosed by ophthalmology based on clinical criteria, angiography and fundoscopy. The location of the RVO (central or peripheral), best corrected visual acuity (BCVA), initial and after one year, the presence of macular oedema, intravitreal treatment (antiangiogenics and dexamethasone implants) and the need for argon laser photo coagulation were recorded. The following clinical variables were recorded: age (yrs.), gender, weight (Kg), height (cm), BMI (Kg/m2), current smoker (yes, no or former > 2 yrs.), alcohol consumption (yes, no, former drinker >2 yrs.), arterial hypertension (AHT > 140-90 mm Hg), diabetes mellitus, hypercholesterolemia, statin use and glaucoma. At the time of the polygraphy, blood pressure readings and were measured total cholesterol (mg/dl), triglycerides (mg/dl), low-density lipoprotein cholesterol (LDL-c) mg/dl, high-density lipoprotein cholesterol (HDL-C) mg/dl, folic acid ng/ml and vitamin B12 pg/ml. Atherogenic index of plasma (LDL/HDL and total cholesterol/HDL-c) was determined.  

纳入标准：

Inclusion criteria

排除标准：

Patients under 18 yrs.

Exclusion criteria：

Patients under 18 yrs.

研究实施时间：

Study execute time：

从 From 2012-06-01 00:00:00至 To 2021-01-09 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2011-12-01 00:00:00 至 To 2020-12-01 00:00:00

干预措施：

Interventions：

组别：

retinal vein occlusion group + osas

样本量：

 21

Group：

retinal vein occlusion group + osas

Sample size：

干预措施：

na

干预措施代码：

Intervention：

na

Intervention code：

组别：

osas group only

样本量：

 21

Group：

osas group only

Sample size：

干预措施：

na

干预措施代码：

Intervention：

na

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 西班牙

省(直辖市)：

 cantabria 

市(区县)：

  

Country：

Spain

Province：

cantabria

City：

santander

单位(医院)：

 Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain 

单位级别：

 Tertiary 

Institution
hospital：

Marqués de Valdecilla University Hospital. Cantabria University. Santander. Spain

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

relationship between both diseases, we analysed the cardiovascular risk profile and polygraphy aspects in a group of patients with OSA and RVO.

指标类型：

主要指标

Outcome：

relationship between both diseases, we analysed the cardiovascular risk profile and polygraphy aspects in a group of patients with OSA and RVO.

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：

标本中文名：

results of ophtalmology exams

组织：

Sample Name：

results of ophtalmology exams

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 90 岁 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）：

not applicable

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

not applicable

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

na

Blinding：

na

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

results are available after request

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

results are available after request

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：

electronic data sheet available

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

electronic data sheet available

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-12-08 05:01:24
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