- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748980
Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease
April 21, 2016 updated by: Liu Zhongwei, Shaanxi Provincial People's Hospital
The purpose of this study is to investigate the prevalence and degree of coronary arterial microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with type 2 diabetes.
Furthermore, the risk factors of coronary arterial microcirulation would be screened and identified.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Na Zhu, Doctor
- Phone Number: 3195 86-29-85251331
- Email: axemaxme2@sina.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710068
- Recruiting
- Shaanxi Provincial People's Hospital
-
Contact:
- Na Zhu, Doctor
- Phone Number: 3194 86-29-85251331
- Email: axemaxme2@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospitalized patients
Description
Inclusion Criteria:
- Diagnosis non- obstructive coronary artery disease;
- Positive Treadmill exercise test;
- Positive Cardiac ECT test;
- Positive Holter test
Exclusion Criteria:
- Diagnosis of myocardial infarction;
- Diagnosis heart failure;
- Diagnosis of chronic kidney disease;
- Diagnosis of heart valvular disease;
- Diagnosis of malignant tumor;
- Positive heart transplant history;
- Pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Non- obstructive coronary artery disease, non- diabetic
Clinical evidences such as Holter, Treadmill exercise test and cardiac ECT support myocardial ischemia.
CAG showed 20%-70% arterial stenosis.
Patients are diagnosed without diabetes.
|
Non- obstructive coronary artery disease, diabetic
Clinical evidences such as Holter, Treadmill exercise test and cardiac ECT support myocardial ischemia.
CAG showed 20%-70% arterial stenosis.
Patients are diagnosed with type 2 diabetes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The coronary microcirculation dysfunction is measured by index of microcirculatory resistance
Time Frame: 10 minutes after diagnosis is made by CAG
|
10 minutes after diagnosis is made by CAG
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
April 17, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 22, 2016
Study Record Updates
Last Update Posted (Estimate)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHJJ20159029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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