Peripheral Arterial DiseaseNCT06887101
Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- atrial fibrillation
- high premature ventricular contractions burden
- pacemaker with constant ventricular pacing
- antiarrhythmic drugs class I or III
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen
Essen, 45147
Julia Lortz, MD, +49201723-84995, julia.lortz@uk-essen.de
About this study
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.
Read the detailed description
Based on World Health Organization data, atherosclerotic cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Peripheral arterial disease (PAD) is a poly-vascular disease in multiple arterial beds mostly associated with high atherosclerotic burden. It is estimated that around 50 million people in Europe alone suffer from PAD and the prevalence increases with age. The cause of CVD, such as PAD, coronary artery disease (CAD) or cerebrovascular disease, is atherosclerosis, a systemic chronic inflammatory vascular disease. Patients with CVD are at increased risk of life-threatening complications such as acute limb events, stroke and myocardial infarction combined with an impaired quality of life.
Acute and chronic stress affect the cardiovascular system. Numerous studies have shown the relationship between chronic stress and cardiovascular diseases. On the one hand, permanent negative stressors lead to cardiovascular diseases via different pathways such as the hypothalamic-pituitary-adrenal (HPA) axis or the autonomic nervous system, and, on the other hand, stress can aggravate an already existing CVD. In addition, cardiovascular risk factors like hypertension and hypercholesteremia are negatively influenced by stress. Stress as a cardiovascular risk factor is receiving increasing attention, leading to its recognition in current guidelines on cardiovascular disease prevention.
Due to the demographic development of an ageing population and the simultaneous increase in atherogenic risk factors, a further rise of patients with CVD will be expected in the future. Thus, sufficient assessment of cardiovascular risk in patients with PAD and adequate stress evaluation are elementary. However, there is a lack of consensus about the definition and measurement of stress.
Therefore, the investigators aim to evaluate and compare the efficiency of different stress measuring methods depending on the occurrence of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with PAD.
- Conditions
- Peripheral Arterial Disease
- Keywords
- vascular diseases, cardiovascular diseases, ischemia, arteriosclerosis, stress
- Medical subject headings
- Peripheral Arterial Disease, Vascular Diseases, Cardiovascular Diseases, Ischemia, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with peripheral arterial disease. | No control group is planned for this trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 6 months, after 12 months
Secondary outcomes (10)
Health-related quality of life
We will apply two instrument to measure health-related quality of life. Namely the Short Form-36 health questionnaire and the European Quality of Life 5 Dimensions 5 Level survey (EQ-5D-5L). The SF-36 is an eight-dimensional scale consisting of 36 items. It assesses health-related quality of life based on physical, social, and psychological functioning, role behavior due to physical and psychological functional impairment, physical pain, general health perception, and vitality. The EQ-5D-5L consists of five health-related dimensions that can be assessed at five levels. In addition, the questionnaire contains a visual analog scale for assessing general health
Measured: Baseline, after 6 months, after 12 months
Ankle-brachial index (ABI)
The lower systolic ankle pressure is set in relation to the systolic blood pressure of the upper extremity. The lowest calculated ABI will be used. Normal values are 0.9 to 1.2. ABI values below 0.9 are indicative of PAD, with an ABI below 0.5 showing severe limb ischaemia
Measured: Baseline, after 6 months, after 12 months
Changes in functional capacity
Changes in functional capacity will be recorded using the established 6-minute walk test
Measured: Baseline, after 6 months, after 12 months
LDL-Cholesterol
Low density lipoprotein (LDL) is measured in mg/dl
Measured: Baseline, after 6 months, after 12 months
Serum-cortisol
Serum-Cortisol is measured in mol/l
Measured: Baseline, after 6 months, after 12 months
Depression symptoms (BDI-II)
The BDI-II is a self-report questionnaire comprising 21 items that assess depression severity. Its reliability and validity have been established through various studies among diverse populations and cultural backgrounds. Higher scores indicates increased depression symptoms
Measured: Baseline, after 6 months, after 12 months
Anxiety symptoms (STAI)
The STAI is the most authoritative tool for assessing anxiety in adults, precisely distinguishing between transient "state anxiety" and persistent "trait anxiety". The STAI measures anxiety with 20 items and has a range of 20 to 80. A higher score indicates more pronounced anxiety.
Measured: Baseline, after 6 months, after 12 months
PROMIS-Anger Scale
The PROMIS Anger scale comprises eight items that evaluate various aspects of anger. Scores on the scale range from 8 to 40, with higher scores indicating greater levels of anger
Measured: Baseline, after 6 months, after 12 months
GHQ
The GHQ assesses general distress and consists of 12 items. Respondents' scores range from 0 to 36, where higher scores correspond to increased distress
Measured: Baseline, after 6 months, after 12 months
Perceived Stress Scale
The Perceived Stress Scale-10 item version is a short tool for the assessment of how individuals perceive stress in their lives. The values range from 0 to 40. Higher values indicate higher perceived stress.
(l) In-treatment assessments: at the start of each intervention module (weekly), the following assessment instruments will be applied: Distress Thermometer (DT), Patient Health Questionnaire-4 (PHQ-4) and self-generated measures to assess coping skills and self-efficacy
Measured: Baseline, after 6 months, after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Duisburg-Essen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887101
- Sponsor's protocol ID
- 23-11092-BO
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06887101
- Acronym / sponsor ID
- 23-11092-BO
- Conditions
- Peripheral Arterial Disease
- Keywords
- vascular diseases, cardiovascular diseases, ischemia, arteriosclerosis, stress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Universität Duisburg-Essen
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Based on World Health Organization data, atherosclerotic cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Peripheral arterial disease (PAD) is a poly-vascular disease in multiple arterial beds mostly associated with high atherosclerotic burden. It is estimated that around 50 million people in Europe alone suffer from PAD and the prevalence increases with age. The cause of CVD, such as PAD, coronary artery disease (CAD) or cerebrovascular disease, is atherosclerosis, a systemic chronic inflammatory vascular disease. Patients with CVD are at increased risk of life-threatening complications such as acute limb events, stroke and myocardial infarction combined with an impaired quality of life.
Acute and chronic stress affect the cardiovascular system. Numerous studies have shown the relationship between chronic stress and cardiovascular diseases. On the one hand, permanent negative stressors lead to cardiovascular diseases via different pathways such as the hypothalamic-pituitary-adrenal (HPA) axis or the autonomic nervous system, and, on the other hand, stress can aggravate an already existing CVD. In addition, cardiovascular risk factors like hypertension and hypercholesteremia are negatively influenced by stress. Stress as a cardiovascular risk factor is receiving increasing attention, leading to its recognition in current guidelines on cardiovascular disease prevention.
Due to the demographic development of an ageing population and the simultaneous increase in atherogenic risk factors, a further rise of patients with CVD will be expected in the future. Thus, sufficient assessment of cardiovascular risk in patients with PAD and adequate stress evaluation are elementary. However, there is a lack of consensus about the definition and measurement of stress.
Therefore, the investigators aim to evaluate and compare the efficiency of different stress measuring methods depending on the occurrence of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with PAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral arterial disease. | – | –No control group is planned for this trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- atrial fibrillation
- high premature ventricular contractions burden
- pacemaker with constant ventricular pacing
- antiarrhythmic drugs class I or III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation
Time frame: Baseline, after 6 months, after 12 months
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
Pychological stress
Time frame: Baseline, after 6 months, after 12 months
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
Heart rate variability (HRV)
Time frame: Baseline, after 6 months, after 12 months
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
Proinflammatory mediators - IL-6
Time frame: Baseline, after 6 months, after 12 months
IL-6 is measured in pg/ml. Standard value is under 2.7 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - IL-1ß
Time frame: Baseline, after 6 months, after 12 months
IL-1ß is measured in pg/ml. Standard value is under 5 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - TNFalpha
Time frame: Baseline, after 6 months, after 12 months
TNFalpha is measured in pg/ml. Standard value is under 2.8 pg/ml. Higher values indicate an increased stress level
Proinflammatory mediators - hsCRP
Time frame: Baseline, after 6 months, after 12 months
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
Hair cortisol concentration
Time frame: Baseline, after 6 months, after 12 months
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
10 secondary outcomes
Health-related quality of life
Time frame: Baseline, after 6 months, after 12 months
Ankle-brachial index (ABI)
Time frame: Baseline, after 6 months, after 12 months
Changes in functional capacity
Time frame: Baseline, after 6 months, after 12 months
LDL-Cholesterol
Time frame: Baseline, after 6 months, after 12 months
Serum-cortisol
Time frame: Baseline, after 6 months, after 12 months
Depression symptoms (BDI-II)
Time frame: Baseline, after 6 months, after 12 months
Anxiety symptoms (STAI)
Time frame: Baseline, after 6 months, after 12 months
PROMIS-Anger Scale
Time frame: Baseline, after 6 months, after 12 months
GHQ
Time frame: Baseline, after 6 months, after 12 months
Perceived Stress Scale
Time frame: Baseline, after 6 months, after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Lortz, MD (+49201723-84995, julia.lortz@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation (time frame: Baseline, after 6 months, after 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.