Peripheral Artery DiseasePAD&CADNCT03921905
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
An observational study of Peripheral Artery Disease, run by Mario Negri Institute for Pharmacological Research at 4 sites in Italy.
Trial summary
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- ABI measurement
- How many people
- 713 participants
- Where
- 4 sitesItaly
- Study dates
- 25 Sep 2019to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.
Who may be able to join
- Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.
Who cannot join
- Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
MEDICOOP Genova
Genova, GE, 16165
Cooperativa Medici Milano Centro
Milan, MI, 20154
MEDICOOP S. Agata
Reggio Calabria, RC, 89134
ROMAMED Service
Rome, RM, 00137
About this study
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.
Read the detailed description
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).
The eligible patients with stable CAD will be called by General Practitioners (GPs).
For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.
At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.
At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.
- Conditions
- Peripheral Artery Disease
- Being tested
- ABI measurement
- Keywords
- Peripheral Artery Disease, Coronary Artery Disease, General Practice, Ankle-brachial index (ABI)
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI measurementDiagnostic test
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
| Study group | Role | What they receive |
|---|---|---|
| Patients with CAD | In this study will be included patients with stable CAD Receives: Diagnostic Test: ABI measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®
The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
Measured: 1 day
Secondary outcomes (39)
To measure the Blood pressure (mmHg)
Measured: 1 day
To measure the Heart rate (bpm)
Measured: 1 day
To measure the Weight (kg)
Measured: 1 day
To measure the Height (cm)
Measured: 1 day
To measure the Body mass index (Kg/m2)
Measured: 1 day
To measure the Ankle Brachial Index (ABI) Value
Measured: 1 day
Clinical History of Limb peripheral artery revascularization
Measured: 1 day
Clinical History of Limb or foot amputation for arterial vascular disease
Measured: 1 day
Clinical History of Clinical presentation of lower extremity disease
Measured: 1 day
Clinical History of Aortic aneurysm
Measured: 1 day
Clinical History of Carotid artery stenosis
Measured: 1 day
Clinical History of Heart Failure
Measured: 1 day
Clinical History of Atrial Fibrillation or Flutter
Measured: 1 day
Clinical History of Hypertension
Measured: 1 day
Clinical History of Dyslipidemia
Measured: 1 day
Clinical History of Chronic Kidney disease
Measured: 1 day
Clinical History of Stroke
Measured: 1 day
Clinical History of Transient ischemic attack
Measured: 1 day
Clinical History of Bleeding
Measured: 1 day
Clinical History of cancer
Measured: 1 day
The dietary habits
The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
Measured: 1 day
Physical activity
The Physical activity Questionnaire (BRFSS 2 items) will be administered
Measured: 1 day
Total cholesterol (mg/dL)
Measured: 1 day
LDL cholesterol (mg/dL)
Measured: 1 day
HDL cholesterol (mg/dL)
Measured: 1 day
Triglycerides (mg/dL)
Measured: 1 day
Glycemia (mg/dL)
Measured: 1 day
Glycated hemoglobin (only for patients with diabetes mellitus) (%)
Measured: 1 day
Creatinine (mg/dL)
Measured: 1 day
Alanine aminotransferase (ALT) (U/L)
Measured: 1 day
Aspartate aminotransferase (AST) (U/L)
Measured: 1 day
Hemoglobin (g/dL)
Measured: 1 day
Platelet count (x 103μL)
Measured: 1 day
Hematocrit (%)
Measured: 1 day
Red blood cells (x10^3 ml)
Measured: 1 day
White blood cells (x10^3 ml)
Measured: 1 day
Marital status
Measured: 1 day
Education Status
Measured: 1 day
Employment status
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start25 Sep 2019
- Primary completion15 Dec 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- 713 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Marta Baviera, PharmD, Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921905
- Sponsor's protocol ID
- IRFMN-7825
- Acronym
- PAD&CAD
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baviera M, Foresta A, Fernandez LO, Torrigiani G, Tettamanti M, Roncaglioni MC, Cimminiello C; PAD, C. A. D. Study Group. Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study. Intern Emerg Med. 2025 Jan;20(1):159-169. doi: 10.1007/s11739-024-03771-9. Epub 2024 Sep 30.
PubMed 39347889
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
- ClinicalTrials.gov ID
- NCT03921905
- Acronym / sponsor ID
- PAD&CAD / IRFMN-7825
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Coronary Artery Disease, General Practice, Ankle-brachial index (ABI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Apr 2019 (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.
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.
Detailed description
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).
The eligible patients with stable CAD will be called by General Practitioners (GPs).
For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.
At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.
At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CAD | – | Diagnostic Test: ABI measurementIn this study will be included patients with stable CAD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.
Key inclusion criteria (1 listed)
- Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.
Key exclusion criteria (1 listed)
- Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI measurementABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD | Diagnostic test | Patients with CAD |
Primary outcome
To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®
Time frame: 1 day
The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
39 secondary outcomes
To measure the Blood pressure (mmHg)
Time frame: 1 day
To measure the Heart rate (bpm)
Time frame: 1 day
To measure the Weight (kg)
Time frame: 1 day
To measure the Height (cm)
Time frame: 1 day
To measure the Body mass index (Kg/m2)
Time frame: 1 day
To measure the Ankle Brachial Index (ABI) Value
Time frame: 1 day
Clinical History of Limb peripheral artery revascularization
Time frame: 1 day
Clinical History of Limb or foot amputation for arterial vascular disease
Time frame: 1 day
Clinical History of Clinical presentation of lower extremity disease
Time frame: 1 day
Clinical History of Aortic aneurysm
Time frame: 1 day
Clinical History of Carotid artery stenosis
Time frame: 1 day
Clinical History of Heart Failure
Time frame: 1 day
Clinical History of Atrial Fibrillation or Flutter
Time frame: 1 day
Clinical History of Hypertension
Time frame: 1 day
Clinical History of Dyslipidemia
Time frame: 1 day
Clinical History of Chronic Kidney disease
Time frame: 1 day
Clinical History of Stroke
Time frame: 1 day
Clinical History of Transient ischemic attack
Time frame: 1 day
Clinical History of Bleeding
Time frame: 1 day
Clinical History of cancer
Time frame: 1 day
The dietary habits
Time frame: 1 day
Physical activity
Time frame: 1 day
Total cholesterol (mg/dL)
Time frame: 1 day
LDL cholesterol (mg/dL)
Time frame: 1 day
HDL cholesterol (mg/dL)
Time frame: 1 day
Triglycerides (mg/dL)
Time frame: 1 day
Glycemia (mg/dL)
Time frame: 1 day
Glycated hemoglobin (only for patients with diabetes mellitus) (%)
Time frame: 1 day
Creatinine (mg/dL)
Time frame: 1 day
Alanine aminotransferase (ALT) (U/L)
Time frame: 1 day
Aspartate aminotransferase (AST) (U/L)
Time frame: 1 day
Hemoglobin (g/dL)
Time frame: 1 day
Platelet count (x 103μL)
Time frame: 1 day
Hematocrit (%)
Time frame: 1 day
Red blood cells (x10^3 ml)
Time frame: 1 day
White blood cells (x10^3 ml)
Time frame: 1 day
Marital status
Time frame: 1 day
Education Status
Time frame: 1 day
Employment status
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Results publication: PubMed 39347889Baviera M, Foresta A, Fernandez LO, Torrigiani G, Tettamanti M, Roncaglioni MC, Cimminiello C; PAD, C. A. D. Study Group. Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study. Intern Emerg Med. 2025 Jan;20(1):159-169. doi: 10.1007/s11739-024-03771-9. Epub 2024 Sep 30.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marta Baviera, PharmD study director
Istituto Di Ricerche Farmacologiche Mario Negri
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Mario Negri Institute for Pharmacological Research at 4 sites in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD® (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921905, which also lists 1 linked publication.
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 3 Dec 2024.