the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia

NCT06220994 | Unknown

• 1 other identifier: 21431-4-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Limb-threatening Ischemia; Microtia

Outcome Measures

Primary Outcomes (1)

• Bacteria or metabolites associated with prolonged survival time without above-knee amputation

  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.

  3years.

Secondary Outcomes (2)

• Key bacteria in CLTI

  up to 1 week

• Key plasma metabolites in CLTI

  up to 1 week

Study Arms (2)

Chronic limb-threatening ischemia

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The Chronic limb-threatening ischemia patients and health adult without history of atherosclerotic plaque, coronary heart disease or stroke, attending Tsinghua Chang Gung Hospital in Beijing.

You may qualify if:

• 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.

You may not qualify if:

• Patients with inflammatory bowel disease, autoimmune diseases, malignancies, infectious diseases, and severe liver and kidney dysfunction (cirrhosis, CKD stage 4 and 5).
• Patients with thromboembolic angiitis, arterial embolism, and takayasu.
• Patients who have used probiotics or antibiotics in the last 2 months.
• After interventional surgery and amputation below the knee or above knee.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood plasma and stool.

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Congenital Microtia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Weiwei Wu, MD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: January 24, 2024
• Study Start: November 15, 2021
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: January 24, 2024

Record last verified: 2023-03

Locations

CN (1)