Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
None listed
Sponsors
Datta Meghe Institute of Higher Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years and above. 2. Diagnosed cases of Type 2 Diabetes Mellitus for at least 1 year. 3.Patients providing informed consent for participation
Exclusion criteria
Exclusion criteria: 1.Severe Comorbidities: Patients with end-stage renal disease (ESRD), advanced heart failure (NYHA Class III/IV), or active malignancy. 2.Severe Uncontrolled Hypertension: Patients with BP >180/110 mmHg despite medication. 3.Pregnancy: Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of Carotid Artery Disease: The percentage of T2DM patients in the rural setting diagnosed with CAD. Identification of Risk Factors: How various risk factors (age, duration of diabetes, hypertension, dyslipidemia, smoking, etc.) contribute to the development of CAD in T2DM patients. Association Between Glycemic Control and CAD: How well-controlled or poorly controlled diabetes affects the incidence or severity of CAD in this cohort. Diagnostic Findings: The use of non-invasive screening methods (e.g., carotid ultrasonography, Doppler studies) to detect early signs of CAD.Timepoint: Baseline (Enrollment) Time Point (Day 0): Objective: To collect initial data on participants before any interventions. Assessments: Medical history (age, duration of T2DM, comorbid conditions such as hypertension, dyslipidemia, etc.). Initial carotid artery screening (e.g., ultrasound or Doppler studies). Measurement of glycemic control (HbA1c), blood pressure, and lipid profiles. Smoking status, BMI, and other relevant demographic information. Follow-up 1 (3-6 Months Post-Baseline): Objective: To monitor early changes in the carotid arteries and update diabetes management. Assessments: Repeat carotid artery screening (e.g., measurement of carotid intima-media thickness, plaque formation). Re-assessment of HbA1c levels, blood pressure, and lipid profiles. Update on treatment adherence (medications, lifestyle modifications). Follow-up 2 (12 Months Post-Baseline): Objective: To evaluate the medium-term effects of screening and disease progression. Assessments: Carotid artery screening (check for plaque progression or new plaque formation). Monitoring of cardiovascular events (e.g., transient ischemic attacks, strokes). Monitoring of metabolic parameters (HbA1c, blood pressure, lipids). End of Study (12-18 Months Post-Baseline): Objective: To assess the final outcomes and progression of CAD in the study cohort. Assessments: Final carotid artery screening. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with carotid artery stenosis of varying severities (mild, moderate, severe) based on Doppler ultrasound findings. Correlation of carotid artery stenosis with clinical parameters like age, gender, BMI, blood pressure, HbA1c levels, lipid profile, duration of T2DM, and smoking history Number of patients referred for further evaluation or treatment (e.g., carotid endarterectomy, lifestyle modifications, or medical therapy) based on screening findings. Incidence of major adverse cardiovascular events (MACE), such as stroke or myocardial infarction, during the follow-up period in screened versus non-screened patients. Economic evaluation of the screening program in terms of cost per patient diagnosed with significant carotid artery disease.Timepoint: Baseline (Time of Enrollment) Record patient demographics, clinical history, physical examination findings, and laboratory results (e.g., HbA1c, lipid profile). Perform carotid Doppler ultrasound to assess carotid artery stenosis. 3-Month Follow-Up: Assess adherence to any recommended treatments (e.g., lifestyle changes, medication for dyslipidemia). Record any changes in clinical parameters (e.g., blood pressure, glycemic control). 6-Month Follow-Up: Reassess clinical and laboratory parameters. Document any cardiovascular events (stroke, TIA, etc.) during this period. Reassess carotid artery status (if indicated) using Doppler ultrasound. | — |
Countries
India
Contacts
Public ContactGankidi Raghavender
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH]
Outcome results
None listed