Painless Myocardial Ischemia in Diabetic Patients.

April 18, 2022 updated by: Zheng Guo, Second Hospital of Shanxi Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Second of Shanxi Medical University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • Subject has diabetes

Exclusion Criteria:

  • History of myocardial ischemia
  • Symptoms of myocardial ischemia（ECG changes except）

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary angiography group
In diabetic patients without symptoms of myocardial ischemia, coronary angiography showed no stenosis or stenosis less than 75%.
Diagnostic test: ELISA 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.
Coronary angiographic stent implantation group
Coronary angiographic stenosis was more than 75% in diabetic patients without myocardial ischemia symptoms, and coronary stents were implanted.
Diagnostic test: ELISA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Shanxi Medical University

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 (Actual)

October 1, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanyi20190825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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