NCT04071808

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

August 26, 2019

Last Update Submit

April 18, 2022

Conditions

Painless Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

  • Blood orphanin content

    Blood orphanin levels in painless diabetic patients with myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy.

    24 hours

  • Blood norepinephrine content

    Blood norepinephrine levels in diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy

    24 hours

Study Arms (2)

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

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

Interventions

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.

Coronary angiographic stent implantation groupCoronary angiography group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Subject has diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

October 1, 2019

Primary Completion

December 30, 2019

Study Completion

March 1, 2020

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting 6 months after publication.

Locations

CN(1)