An observational study in Type 2 Diabetes Mellitus and Coronary Heart Disease, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Second Affiliated Hospital of Nanchang University · Observational
Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 120 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
120
Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
Clinical diagnosis of Acute Coronary Syndrome (ACS).
Exclusion Criteria:
History of hemodialysis.
Recent antibiotic use within the past two weeks.
Active malignant tumors.
Pregnancy and breastfeeding.
Inability to wear sensors due to severe skin conditions.
Coagulation disorders, anemia, or abnormal hematocrit levels.
Requirement for MRI during the sensor-wearing period.
Inability to follow study instructions or deemed unsuitable for the trial by the treating clinician/nurse.
Inability to understand informed consent or communicate with researchers due to cognitive decline or mental illness.
Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography.
Device: Continuous glucose monitoring
Subjects with T2DM and acute coronary syndrome (n=120) were fitted with continuous glucose monitors (CGM) to closely monitor their blood glucose levels continuously for 14 days.
Major adverse cardiovascular events
Composite Major Adverse Cardiovascular Events (MACE)
Time frame: 2023.7-2025.10
cardiovascular mortality
Deaths due to heart and/or vascular disease. According to the World Health Organisation (WHO) classification, cardiovascular diseases include a wide range of diseases such as coronary heart disease, myocardial infarction, stroke and hypertension.
Time frame: 2023.7-2025.10
ACS Recurrence
Refers to the recurrence of a new ACS event after an episode of ACS. Depending on the signs and symptoms, patients can be classified as having STEMI, NSTEMI, or unstable angina.
Time frame: 2023.7-2025.10
Angina requiring revascularisation
Presence of indications for coronary revascularisation
Time frame: 2023.7-2025.10
Acute decompensated heart failure requiring hospitalisation
Clinical syndrome caused by acute imbalance of oxygen supply and demand due to impaired cardiac function, manifested by dyspnoea, pulmonary oedema and peripheral oedema. The patient's condition is severe enough to require hospitalisation.
Time frame: 2023.7-2025.10
Strokes requiring hospitalisation
An acute disease with sudden defects in brain function, such as sudden motor, sensory, speech, and vision disorders. The patient's condition is serious enough to require hospitalisation for treatment and observation.
Time frame: 2023.7-2025.10
Plan to share: No — Privacy and confidentiality issues: Participants' data may contain sensitive personal information. Sharing this data could lead to privacy breaches, violating data protection regulations (such as GDPR).
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Second Affiliated Hospital of Nanchang University