Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease

NCT06887101 | Recruiting

• 1 other identifier: 23-11092-BO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality worldwide. Patients with peripheral arterial disease are at increased risk suffering from major adverse cardiac and limb events. Acute and chronic stress affect the cardiovascular system. Long-term negative stressors lead to cardiovascular diseases and can aggravate already existing cardiovascular diseases. However, current guidelines on cardiovascular disease prevention highlight stress as a cardiovascular risk factor there is a lack of consensus about the definition and measurement of stress. The aim of the proposed trial is to evaluate different stress measuring methods in patients with PAD depending on the occurrence of cardiovascular events.

Conditions

Peripheral Arterial Disease

Keywords

vascular diseases; cardiovascular diseases; ischemia; arteriosclerosis; stress

Outcome Measures

Primary Outcomes (8)

• Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation

  Based on the COMPASS trial MACE and MALE includes the composite of cardiovascular death, myocardial infarction, acute limb ischaemia, chronic limb ischaemia and amputation. MACE and MALE will be evaluated at baseline and after 6 and 12 months

  Baseline, after 6 months, after 12 months

• Pychological stress

  Pychological stress is evaluated by a composite psychometric measure of stress level by using a mean rank at baseline and after 1 year. It is based on a published RCT by Blumenthal et al. and includes the Beck Depression Inventory II (BDI-II), State-Trait Anxiety inventory (STAI), Patient-Reported Outcomes Measurement Information System (PROMIS) Anger, General Health Questionnaire (GHQ) and Perceived Stress Scale (PSS). A range from 1 to 147 was present with higher scores suggestive of better function

  Baseline, after 6 months, after 12 months

• Heart rate variability (HRV)

  Heart rate variability (HRV) is an indirect marker of autonomic nervous system activity and describes the oscillations between the R-R intervals in the electrocardiogram. It allows a relatively superficial insight into the heart-brain interaction and reflects the psycho-emotional status such as stress or anxiety. According to the guidelines we chose a short-time HRV with 5 minutes of recording

  Baseline, after 6 months, after 12 months

• Proinflammatory mediators - IL-6

  IL-6 is measured in pg/ml. Standard value is under 2.7 pg/ml. Higher values indicate an increased stress level

  Baseline, after 6 months, after 12 months

• Proinflammatory mediators - IL-1ß

  IL-1ß is measured in pg/ml. Standard value is under 5 pg/ml. Higher values indicate an increased stress level

  Baseline, after 6 months, after 12 months

• Proinflammatory mediators - TNFalpha

  TNFalpha is measured in pg/ml. Standard value is under 2.8 pg/ml. Higher values indicate an increased stress level

  Baseline, after 6 months, after 12 months

• Proinflammatory mediators - hsCRP

  High sensitive-c-reactive protein (hsCRP) is measured in mg/dl. Standard value is under 0.02 mg/dl. Higher values indicate an increased stress level

  Baseline, after 6 months, after 12 months

• Hair cortisol concentration

  Hair cortisol is reliable biomarker of chronic stress that offers a retrospective non-invasive measurement of long-term HPA-axis activity over several weeks or months. The cortisol concentration, measured in pg/ml, of a 3 cm hair segment using liquid chromatography tandem mass spectrometry will be analyzed. Higher values indicate an increased stress level

  Baseline, after 6 months, after 12 months

Secondary Outcomes (10)

• Health-related quality of life

  Baseline, after 6 months, after 12 months

• Ankle-brachial index (ABI)

  Baseline, after 6 months, after 12 months

• Changes in functional capacity

  Baseline, after 6 months, after 12 months

• LDL-Cholesterol

  Baseline, after 6 months, after 12 months

• Serum-cortisol

  Baseline, after 6 months, after 12 months

Study Arms (1)

Patients with peripheral arterial disease.

No control group is planned for this trial.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The recruitment process and examinations will take place at the Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen.

You may qualify if:

• Diagnosis of lower extremity PAD based on:
• Limb bypass surgery or
• aorta-femoral bypass surgery or
• percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries or
• limb or foot amputation for arterial vascular disease or
• intermittent claudication and one or more of either an ankle brachial index (ABI) of less than 0.90 or a peripheral artery stenosis (≥50%) documented by angiography or duplex ultrasound or carotid revascularization or asymptomatic carotid artery stenosis of at least 50% diagnosed by duplex ultrasound or angiography

You may not qualify if:

• atrial fibrillation
• high premature ventricular contractions burden
• pacemaker with constant ventricular pacing
• antiarrhythmic drugs class I or III

Sponsors & Collaborators

• University Hospital, Essen: lead
• Universität Duisburg-Essen: collaborator

Study Sites (1)

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen

Essen, 45147, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Hair cortisol. Standard blood tests.

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Diseases; Cardiovascular Diseases; Ischemia; Arteriosclerosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Julia Lortz, MD

CONTACT

+49201723-84995; julia.lortz@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 20, 2025
• Study Start: April 21, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publication
• Access Criteria: contact PI

Locations

DE (1)