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A plasma biomarker study for coronary angiopathy in diabetes mellitus: a multicenter case-control study clinical trial protocol

A plasma biomarker study for coronary angiopathy in diabetes mellitus: a multicenter case-control study clinical trial protocol

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042943
Enrollment
Unknown
Registered
2021-02-01
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Diabetes mellitus complicated with coronary vascular disease group:Nil
Diabetes mellitus group without coronary vascular disease:Nil

Sponsors

Tangdu Hospital of Air Force Millitary Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who met all of the following criteria could be included: (1) Aged >= 18 and = 11.1mmol/L (200mg/dL), or fasting blood glucose >= 7.0mmol/L (126mg/dL), or blood glucose >= 11.1mmol/L 2 hours after 75g glucose load (200mg/dL); (4) 5-10 years after diagnosis of diabetes; (5) HbA1c <= 7.0% (according to HbA1c results in recent 6 months); (6) Signed written informed consent.

Exclusion criteria

Exclusion criteria: Those who have one or more of the following will not be included in the study: (1) Patients with previously diagnosed coronary atherosclerotic heart disease; (2) Patients previously diagnosed with stroke, transient ischemic attack, aortic aneurysm or peripheral artery disease; (3) Patients who plan to undergo cardiac surgery or cardiac interventional therapy in the next 6 months; (4) Patients who were taking antiplatelet drugs (such as aspirin, clopidogrel, ticagrelor, etc.) at admission; (5) Patients who meet any of the following criteria: Examination on admission suggested proteinuria; EGFR 65 years, male age > 60 years; Previous confirmed hypertension; On admission, examination suggested dyslipidemia (total cholesterol >= 5.2mmol/L, triglyceride >= 1.7mmol/L, HDL = 4.11mmol/L) or was taking lipid-regulating drugs at admission; Has a history of smoking and was still smoking at admission; BMI 28 kg/m2 or (7) Patients with severe abnormal liver function at admission, specifically defined as ALT or AST >= 3 times normal value; (8) Patients with severe renal dysfunction at admission, specifically defined as BUN >= 3 times normal value or SCR >= 3 times normal value; (9) Patients with previously diagnosed severe autoimmune diseases; (10) Patients with previously diagnosed malignant tumors; (11) Patients with a history of surgery, trauma or acute or chronic infection within one month before admission; (12) Women who were pregnant at the time of admission or who planned to be pregnant within 6 months; (13) Patients participating in other clinical trials (other than other subjects of this project) who did not meet the time limit of the primary study endpoint; (14) The investigator determined that there were other reasons for the patients not to participate in the study; (15) The researcher judged patients with poor compliance and unable to complete the study as required.

Design outcomes

Primary

MeasureTime frame
Plasma marker level;

Secondary

MeasureTime frame
Sensitivity of plasma markers;Specificity of plasma markers;The OR value, P value and partial regression coefficient of multivariate Logistic regression were obtained;

Countries

China

Contacts

Public ContactLi Yan

Tangdu Hospital of Air Force Millitary Medical University

307712565@qq.com+86 13892890227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026