Chronic Limb-threatening Ischemia, Microtia
Conditions
Brief summary
Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on coronary atherosclerotic disease (CAD) population, or atherosclerosis model animals such as ApoE-/-, LDLR-/- high-fat diet mice, and there are few studies on Chronic limb-threatening ischemia (CLTI). CLTI and CAD have a similar pathological basis of atherosclerosis. It is unclear whether intestinal flora plays an essential role in the occurrence and development of CLTI. This project aims to explore the relation between microorganisms, metabolites, and CLTI.
Detailed description
This project aims to study the intestinal flora and its metabolites in patients with CLTI, explore whether CLTI patients and CAD patients have their own characteristic flora, analyze the microorganisms and metabolites markers of poor prognosis in patients with CLTI, and screen out the key differential bacteria and metabolites that inhibit the progress of CLTI, in order to provide new insights and research basis for the treatment of CLTI.
Interventions
None listed
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Control group: sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke). Case group: resting pain for at least 2 weeks with at least one hemodynamic index: ABI\<0.4,AP\<50mmHg, TP or TCPO2\<30mmHg. Tissue defects (ulceration or gangrene) persisted for at least 2 weeks with at least one significant PAD objective evidence: ABI\<0.8, AP\<100mmHg, TP or TCPO2\<60mmHg.
Exclusion criteria
1. Patients with inflammatory bowel disease, autoimmune diseases, malignancies, infectious diseases, and severe liver and kidney dysfunction (cirrhosis, CKD stage 4 and 5). 2. Patients with thromboembolic angiitis, arterial embolism, and takayasu. 3. Patients who have used probiotics or antibiotics in the last 2 months. 4. After interventional surgery and amputation below the knee or above knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteria or metabolites associated with prolonged survival time without above-knee amputation | 3years. | The relationship between the prognosis and gut microbiota or plasma metabolomics was analyzed. Spearman correlations between CAGs, serum metabolite modules and clinical parameters were calculated using R, and both differential abundances of CAGs and CLTI-associated metabotypes were tested by the Wilcoxon rank sum test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key bacteria in CLTI | up to 1 week | Differential bacteria enriched in healthy group but absent in CLTI patients were explored by metagenomic analysis of the gut microbiota. It includes species composition and abundance analysis, beta diversity, differences between groups, and RDA/CCA. |
| Key plasma metabolites in CLTI | up to 1 week | Differential metabolites enriched in healthy group but absent in CLTI patients were explored by non-targeted metabolomics analysis of the gut contents. It includes sample grouping data analysis, metabolites annotation, and screening of differential metabolites. |
Countries
China
Outcome results
None listed