Mild cognitive impairment in elderly with coronary heart disease
Conditions
Interventions
The treatment group:Tongxin Yinao granules+ conventional Western medicine treatment
The control group:Tongxin Yinao granules placebo + conventional Western medicine treatment
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for coronary artery disease in the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guidelines for the Management of Patients with Chronic Coronary Artery Disease: a report of the Joint American Heart Association/American College of Cardiology Clinical Practice Guidelines Committee; (2) Meet the diagnostic criteria for mild cognitive impairment: refer to China's 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment: Diagnostic Criteria for the Diagnosis and Treatment of Mild Cognitive Impairment; (3) To formulate the diagnostic criteria for TCM symptoms of elderly coronary heart disease MCI with renal deficiency and blood stasis with reference to the "Guidelines for Clinical Research of New Chinese Medicines" and the diagnostic criteria for renal deficiency and blood stasis, and to meet the diagnostic criteria for renal deficiency and blood stasis; (2) Age =65 and =80 years old, gender is not limited; (3) Visual and auditory discrimination is relatively intact, and they are able to cooperate in completing the relevant assessments; (4) Agree to participate in the study and sign the informed consent form; (5) Not participating in other clinical trials.
Exclusion criteria
Exclusion criteria: (1) Dementia of all causes with a diagnosis of DSM-IV diagnostic criteria for dementia, a history of severe head trauma with persistent neurologic deficits or known structural brain abnormalities; (2) A history of psychiatric abnormalities, drug or alcohol abuse or dependence within the prior 5 years; (3) Patients taking Chinese herbal medicines with tonic effects, anticholinergics, anticonvulsants, antiparkinsonian, excitatory, cholinergic, antipsychotics, such as donepezil, carboplatin, galantamine, and strychnine A, within 1 month prior to the trial; (4) Patients with severe hepatic or renal insufficiency, e.g., ALT or AST more than 1.5 times the normal value, or blood creatinine or urea nitrogen more than 1.2 times the normal value range, creatinine clearance CrCl <60 mL/min, coagulation dysfunction, etc. Patients who are expected to be unable to complete the test; (5) Patients who have been allergic to the test medication or intolerant to taking medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire;Montreal Cognitive Assessment score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NLR;cIMT;FGF-21;Fibulin-1;TCM syndrome score;ABI;baPWV; | — |
Countries
China
Contacts
Public ContactFengqin Xu
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed