complex coronary heart disease and diabetes mellitus
Conditions
Interventions
Noninvasive vagus nerve stimulation group:Patients in the noninvasive vagus nerve stimulation groupl received low-intensity noninvasive vagus nerve stimulation (nVNS) using a noninvasive vagus nerve s
Sham noninvasive vagus nerve stimulation group:Patients in the sham noninvasive vagus nerve stimulation group received sham noninvasive vagus nerve stimulation (sham nVNS) at the same time schedule as
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age greater than 18 years; 2.Patients diagnosed with type 2 diabetes mellitus (T2DM). Diagnosis should meet the American Diabetes Association (ADA) criteria, defined as the presence of any of the following: (1)Hemoglobin A1c (HbA1c) >= 6.5%; (2)Fasting plasma glucose (FPG) >= 126 mg/dL (>= 7.0 mmol/L):Fasting is defined as no caloric intake for at least 8 hours; (3) 2-hour plasma glucose (2-h PG) >= 200 mg/dL (>= 11.1 mmol/L):This test should be performed using a 75-g anhydrous glucose load dissolved in water for the oral glucose tolerance test (OGTT), according to World Health Organization (WHO) recommendations; (4)In patients with classic symptoms of hyperglycemia or hyperglycemic crisis, random plasma glucose >= 200 mg/dL (>= 11.1 mmol/L):"Random" refers to any time of the day, without regard to the timing of the previous meal; 3.Patients with multivessel coronary artery disease (CAD):Coronary angiography shows multivessel disease, defined as stenosis >= 70% in two or more major coronary arteries or stenosis >= 50% in the left main coronary artery, or a history of revascularization in two or more major coronary arteries or the left main coronary artery.
Exclusion criteria
Exclusion criteria: 1.Myocardial injury secondary to severe or rapid arrhythmia, drug toxicity, or shock; 2.Post–pacemaker implantation; 3.Autoimmune diseases or hematologic disorders; 4.Acute infections or chronic inflammatory diseases; 5.Presence of severe valvular heart disease; 6.Severe renal impairment (estimated glomerular filtration rate, eGFR 3 times the upper limit of normal); 9.Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events;Cardiac magnetic resonance imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine examination result;24-hour ambulatory electrocardiogram data;Liver and kidney function;Echocardiography data;F ractional f low reserve;Inflammatory factor; | — |
Countries
China
Contacts
Public ContactZhou Xiaoya
Renmin Hospital of Wuhan University
Outcome results
None listed