Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

NCT ID: NCT05111379

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2025-08-31

Brief Summary

The most common clinical presentation of lower extremity arterial disease is intermittent claudication. Current understanding of the pathophysiology of intermittent claudication, as well as its treatment options are limited. The progression of the disease may lead to lower limb amputation, which is devastating for patients' quality of life and is a huge socio-economic burden to society.

Current study allows to determine the acute local metabolomic alterations in the ischaemic limb of the patient with intermittent claudication, and investigate the associations between the metabolomic alterations and the patient's maximal walking distance. This provides potentially valuable insight into the pathophysiology of this disease, and helps lay the groundwork for identifying potential novel targets for instituting more effective therapies for this high-risk population.

Conditions

Peripheral Arterial Occlusive Disease Fontaine Stage IIa

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

LEAD (Fontaine IIa)

Patients with mild intermittent claudication.

No interventions assigned to this group

Control

Healthy controls.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• LEAD group: Patients with diagnosis of lower extremity arterial disease (Fontaine IIa).
• Control group: Healthy volunteers with no leg symptoms and an ankle-brachial index (ABI) of 1.0-1.4.

Exclusion Criteria

• Fontaine stages I or IIb-IV
• Exacerbation of limb ischaemia within the preceding 2 weeks;
• strong rest pain of any cause;
• age <18 or >80 years;
• fasting < 6 hours;
• time since last use of tobacco products < 6 hours;
• body mass index ≥ 35 kg/m2
• poor sonographic visibility of femoral artery;
• angina;
• cardiac arrhythmia at the time of presentation;
• presence of cardiac pacemaker;
• myocardial infarction within the preceding 3 months;
• stroke within the preceding 6 months;
• ongoing anticoagulant therapy;
• ongoing dual antiplatelet therapy;
• any revascularization within the preceding 3 month;
• marked heart failure (NYHA III-IV);
• blood pressure ≥ 180/110 mmHg;
• blood pressure <100/70 mmHg;
• clinically significant heart valve disease;
• acute infectious disease;
• active malignancy or chemotherapy or disease-free < 5 years;
• type I diabetes or insulin therapy;
• other clinically significant and untreated endocrine disorders;
• moderate to severe bronchial asthma (GINA 2016);
• severe chronic obstructive pulmonary disease (mMRC grade 3-4);
• acute (KDIGO 2012) or chronic renal disease (eGFR-EPI <30mL/min/1.73 m2);
• acute or chronic liver disease;
• anemia (<110 g/L);
• neuroinflammatory or neurodegenerative disease;
• active rheumatism;
• other diseases and factors that markedly hinder the subject's ability to walk during the treadmill exercise.
• For control group exclusively: history of lower extremity arterial disease / ABI <1.0 or >1.4.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tartu University Hospital

OTHER

Sponsor Role: collaborator

Estonian Science Foundation

OTHER_GOV

Sponsor Role: collaborator

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Jaak Kals, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaak Kals, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Kaido Paapstel, MD, PhD

Role: STUDY_CHAIR

University of Tartu

Kalle Kilk, MD, PhD

Role: STUDY_CHAIR

University of Tartu

Holger Post, MD

Role: STUDY_CHAIR

University of Tartu

Locations

Tartu University Hospital

Tartu, Tartu, Estonia

Site Status: RECRUITING

Countries

Estonia

Central Contacts

Jaak Kals, MD, PhD

Role: CONTACT

jaak.kals@kliinikum.ee

+372 731 8292

Facility Contacts

Jaak Kals, MD, PhD

Role: primary

jaak.kals@kliinikum.ee

+372 731 8292

Related Links

https://endothelialcentre.ut.ee/

Endothelial Research Centre

Other Identifiers

350/T-2

Identifier Type: -

Identifier Source: org_study_id