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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03404037
Other study ID # 3527/20-2-2017
Secondary ID
Status Completed
Phase N/A
First received January 11, 2018
Last updated January 18, 2018
Start date March 2, 2017
Est. completion date December 20, 2017

Study information

Verified date January 2018
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.


Description:

elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date December 20, 2017
Est. primary completion date November 11, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - Patients were between the ages of 50 and 70 years at enrollment.

- Symptomatic or previously recognized coronary artery disease for all the study population.

- Type 2 diabetic patients with the onset of type 2 diabetes occurred at age 30 years or older with no history of ketoacidosis for group II subjects.

Exclusion Criteria:

- left ventricular ejection fraction (LVEF) =40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index < 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index >30 kg/m2 or < 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.

Study Design


Intervention

Diagnostic Test:
serum endostatin level
An oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding. Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R&D Systems, Minneapolis, Minnesota, USA

Locations

Country Name City State
Egypt Zagazig University, Faculty of Medicine Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients. 3-Months
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