the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia (MMM)

Beijing Tsinghua Chang Gung Hospital

Status: Invitation-only

Conditions: Chronic Limb-threatening Ischemia; Microtia

Study type: Observational

Funder types: Other

Identifiers

NCT06220994

21431-4-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Chronic limb-threatening ischemia

Description:

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.

health control

Description:

sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke).