Painless Myocardial IschemiaNCT04071808
Painless Myocardial Ischemia in Diabetic Patients.
An observational study of Painless Myocardial Ischemia, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painless Myocardial Ischemia
- What is being tested?
- ELISA Test
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Subject has diabetes
Who cannot join
- History of myocardial ischemia
- Symptoms of myocardial ischemia（ECG changes except）
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Plasma Orphanin and Norepinephrine Levels in Patients With Painless Myocardial Ischemia and Diabetes Mellitus.
This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for screening high risk patients in the diabetes sufferers to prevent the painless myocardial ischemia.
- Conditions
- Painless Myocardial Ischemia
- Being tested
- ELISA Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA TestDiagnostic test
The levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured.
| Study group | Role | What they receive |
|---|---|---|
| Coronary angiography group | In diabetic patients without symptoms of myocardial ischemia, coronary angiography showed no stenosis or stenosis less than 75%. Receives: Diagnostic Test: ELISA Test | |
| Coronary angiographic stent implantation group | Coronary angiographic stenosis was more than 75% in diabetic patients without myocardial ischemia symptoms, and coronary stents were implanted. Receives: Diagnostic Test: ELISA Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood orphanin content
Blood orphanin levels in painless diabetic patients with myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy.
Measured: 24 hours
Blood norepinephrine content
Blood norepinephrine levels in diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless Myocardial IschemiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071808
- Sponsor's protocol ID
- hanyi20190825
- Status last verified
- Apr 2022
- First submitted
- 26 Aug 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Plasma Orphanin and Norepinephrine Levels in Patients With Painless Myocardial Ischemia and Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04071808
- Acronym / sponsor ID
- hanyi20190825
- Conditions
- Painless Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for screening high risk patients in the diabetes sufferers to prevent the painless myocardial ischemia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary angiography group | – | Diagnostic Test: ELISA TestIn diabetic patients without symptoms of myocardial ischemia, coronary angiography showed no stenosis or stenosis less than 75%. |
| Coronary angiographic stent implantation group | – | Diagnostic Test: ELISA TestCoronary angiographic stenosis was more than 75% in diabetic patients without myocardial ischemia symptoms, and coronary stents were implanted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Subject has diabetes
Key exclusion criteria (2 listed)
- History of myocardial ischemia
- Symptoms of myocardial ischemia（ECG changes except）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA TestThe levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured. | Diagnostic test | Coronary angiographic stent implantation group, Coronary angiography group |
Primary outcome
Blood orphanin content
Time frame: 24 hours
Blood orphanin levels in painless diabetic patients with myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy.
Blood norepinephrine content
Time frame: 24 hours
Blood norepinephrine levels in diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Painless Myocardial Ischemia, run by Second Hospital of Shanxi Medical University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood orphanin content (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 20 Apr 2022.