Cross-sectional investigation of the characteristics of intestinal flora in patients with carotid atherosclerotic plaque ulcer

Registration number:

ITMCTR2100005005

Date of Last Refreshed on:

2021-03-04

Date of Registration:

2021-03-04

Registration Status:

Prospective registration

Public title:

Cross-sectional investigation of the characteristics of intestinal flora in patients with carotid atherosclerotic plaque ulcer

English Acronym:

Scientific title:

Cross-sectional investigation of the characteristics of intestinal flora in patients with carotid atherosclerotic plaque ulcer

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100043829 ; ChiMCTR2100005005

Applicant:

Wang Kebin

Study leader:

Wu Shengxian

Applicant telephone:

+86 15801365569

Study leader's telephone:

+86 13501382919

Applicant Fax:

Study leader's fax:

Applicant E-mail:

wkbwangkebin@sina.com

Study leader's E-mail:

wushx@sina.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

5 Haiyuncang Lane, Dongcheng District, Beijing, China

Study leader's address:

5 Haiyuncang Lane, Dongcheng District, Beijing, China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

DZMEC-KY-2020-74

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Date of approved by ethic committee:

2020/8/24 0:00:00

Contact Name of the ethic committee:

Xue Wanjun, Xue Chunmiao

Contact Address of the ethic committee:

5 Haiyuncang Lane, Dongcheng District, Beijing, China

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Primary sponsor's address:

5 Haiyuncang Lane, Dongcheng District, Beijing, China

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Institution
hospital:

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

Address:

5 Haiyuncang Lane, Dongcheng District

Source(s) of funding:

Research funds

Target disease:

Carotid atherosclerotic plaque ulcer

Target disease code:

Study type:

Observational study

Study design:

Factorial

Study phase:

Others

Objectives of Study:

Use cross-sectional survey research methods to study the intestinal flora and the distribution characteristics of TCM syndrome elements in patients with carotid atherosclerotic plaque ulcer.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

Exposure group: Patients with carotid atherosclerotic plaque ulcer diagnosed by color Doppler ultrasound; The patients with lumen stenosis < 75% were selected; Subjects with at least one risk factor were hypertension or diabetes or hyperlipidemia. The subjects aged from 40 to 70 were not limited in gender; The patient informed consent and signed the informed consent form. Non exposure group: The patients with carotid atherosclerotic plaque but no ulcer were diagnosed by color Doppler ultrasound; Patients with lumen stenosis less than 75%; Subjects with at least one risk factor were hypertension or diabetes or hyperlipidemia. The subjects aged from 40 to 70 were not limited in gender; The patient informed consent and signed the informed consent form.

Exclusion criteria:

Exposure group: Patients with acute stroke or myocardial infarction in recent 3 months were excluded; Patients with severe arrhythmia, atrial fibrillation and heart failure were excluded; Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and respiratory system were excluded; Patients with abnormal stool were excluded; Patients who were taking antibiotics were excluded; Pregnant women were excluded. Non exposure group: Patients with acute stroke or myocardial infarction in recent 3 months were excluded; Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and respiratory system were excluded; Patients with abnormal stool were excluded; Patients who were taking antibiotics were excluded; Pregnant women were excluded.

Study execute time:

From 2020-08-24

To      2022-08-24

Recruiting time:

From 2021-03-04

To      2022-08-24

Interventions:

90

Group:

carotid atherosclerotic plaque but no ulcer

Sample size:

Intervention:

Nil

Intervention code:

90

Group:

carotid atherosclerotic plaque ulcer

Sample size:

Intervention:

Nil

Intervention code:

Total sample size : 180

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Institution/hospital:

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Distribution characteristics of TCM syndrome elements

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Blood chemistry

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Blood routine

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Intestinal flora

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

stool

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

40
Min age years
80
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

N/A

Blinding:

N/A

IPD sharing:

Yes

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

Share raw data on designated network platforms within 6 months of trial completion

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

1. Fill in the observation form The investigator filled out the observation form in a timely, complete, correct and clear manner based on the subjects’ hospitalization medical records and original observation records. 2. Build a database Before data entry, the data manager should understand the content and coding situation of each item in the observation form, and record the coding process in the codebook. The database naming should be standardized, easy to read and easy to find. And to ensure its accuracy, safety and confidentiality.

Data Managemen Committee:

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above