Complications of Diabetes MellitusNCT02748980
Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease
An observational study of Complications of Diabetes Mellitus and Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complications of Diabetes Mellitus, Coronary Artery Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- Diagnosis non- obstructive coronary artery disease;
- Positive Treadmill exercise test;
- Positive Cardiac ECT test;
- Positive Holter test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Na Zhu, Doctor, 86-29-85251331 ext. 3194, axemaxme2@sina.com
About this study
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.
- Medical subject headings
- Diabetes Complications, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The coronary microcirculation dysfunction is measured by index of microcirculatory resistance
Measured: 10 minutes after diagnosis is made by CAG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhongwei, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748980
- Sponsor's protocol ID
- LHJJ20159029
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Coronary Arterial Microcirculation Dysfunction in Diabetic Patients With Non- Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02748980
- Acronym / sponsor ID
- LHJJ20159029
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (4 listed)
- Diagnosis non- obstructive coronary artery disease;
- Positive Treadmill exercise test;
- Positive Cardiac ECT test;
- Positive Holter test
Key exclusion criteria (7 listed)
- Diagnosis of myocardial infarction;
- Diagnosis heart failure;
- Diagnosis of chronic kidney disease;
- Diagnosis of heart valvular disease;
- Diagnosis of malignant tumor;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The coronary microcirculation dysfunction is measured by index of microcirculatory resistance
Time frame: 10 minutes after diagnosis is made by CAG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Diabetes Mellitus and Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Zhu, Doctor (86-29-85251331 ext. 3195, axemaxme2@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coronary microcirculation dysfunction is measured by index of microcirculatory resistance (time frame: 10 minutes after diagnosis is made by CAG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.