NCT02748980

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

April 17, 2016

Last Update Submit

April 21, 2016

Conditions

Complications of Diabetes MellitusCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The coronary microcirculation dysfunction is measured by index of microcirculatory resistance

    10 minutes after diagnosis is made by CAG

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients

You may qualify if:

  • Diagnosis non- obstructive coronary artery disease;
  • Positive Treadmill exercise test;
  • Positive Cardiac ECT test;
  • Positive Holter test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

MeSH Terms

Conditions

Diabetes ComplicationsCoronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Na Zhu, Doctor

CONTACT

86-29-85251331axemaxme2@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 22, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

CN(1)