Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. (PAD&CAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921905
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief 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. 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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Diagnostic Test: ABI measurement

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), pharmacological therapy and adherence to treatments. 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : July 21, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with CAD
In this study will be included patients with stable CAD
Diagnostic Test: ABI measurement
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To measure the Blood pressure (mmHg) [ Time Frame: 1 day ]
  2. To measure the Heart rate (bpm) [ Time Frame: 1 day ]
  3. To measure the Weight (kg) [ Time Frame: 1 day ]
  4. To measure the Height (cm) [ Time Frame: 1 day ]
  5. To measure the Body mass index (Kg/m2) [ Time Frame: 1 day ]
  6. To measure the Ankle Brachial Index (ABI) Value [ Time Frame: 1 day ]
  7. Clinical History of Limb peripheral artery revascularization [ Time Frame: 1 day ]
  8. Clinical History of Limb or foot amputation for arterial vascular disease [ Time Frame: 1 day ]
  9. Clinical History of Clinical presentation of lower extremity disease [ Time Frame: 1 day ]
  10. Clinical History of Aortic aneurysm [ Time Frame: 1 day ]
  11. Clinical History of Carotid artery stenosis [ Time Frame: 1 day ]
  12. Clinical History of Heart Failure [ Time Frame: 1 day ]
  13. Clinical History of Atrial Fibrillation or Flutter [ Time Frame: 1 day ]
  14. Clinical History of Hypertension [ Time Frame: 1 day ]
  15. Clinical History of Dyslipidemia [ Time Frame: 1 day ]
  16. Clinical History of Chronic Kidney disease [ Time Frame: 1 day ]
  17. Clinical History of Stroke [ Time Frame: 1 day ]
  18. Clinical History of Transient ischemic attack [ Time Frame: 1 day ]
  19. Clinical History of Bleeding [ Time Frame: 1 day ]
  20. Clinical History of cancer [ Time Frame: 1 day ]
  21. To assess Treatment Adherence [ Time Frame: 1 day ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered Minimum Score: 0, Maximum Score: 8 If the score if between 0 and 5, the adherence is low (worse outcome) If the score if between 6 and 7, the adherence is low-medium If the score is 8, the adherence is high (better outcome)

  22. The dietary habits [ Time Frame: 1 day ]
    The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered

  23. Physical activity [ Time Frame: 1 day ]
    The Physical activity Questionnaire (BRFSS 2 items) will be administered

  24. Total cholesterol (mg/dL) [ Time Frame: 1 day ]
  25. LDL cholesterol (mg/dL) [ Time Frame: 1 day ]
  26. HDL cholesterol (mg/dL) [ Time Frame: 1 day ]
  27. Triglycerides (mg/dL) [ Time Frame: 1 day ]
  28. Glycemia (mg/dL) [ Time Frame: 1 day ]
  29. Glycated hemoglobin (only for patients with diabetes mellitus) (%) [ Time Frame: 1 day ]
  30. Creatinine (mg/dL) [ Time Frame: 1 day ]
  31. Alanine aminotransferase (ALT) (U/L) [ Time Frame: 1 day ]
  32. Aspartate aminotransferase (AST) (U/L) [ Time Frame: 1 day ]
  33. Hemoglobin (g/dL) [ Time Frame: 1 day ]
  34. Platelet count (x 103μL) [ Time Frame: 1 day ]
  35. Hematocrit (%) [ Time Frame: 1 day ]
  36. Red blood cells (x10^3 ml) [ Time Frame: 1 day ]
  37. White blood cells (x10^3 ml) [ Time Frame: 1 day ]
  38. Marital status [ Time Frame: 1 day ]
  39. Education Status [ Time Frame: 1 day ]
  40. Employment status [ Time Frame: 1 day ]

Other Outcome Measures:
  1. The incidence of Acute coronary syndrome [ Time Frame: 12 months ]
  2. The incidence of Stroke [ Time Frame: 12 months ]
  3. The incidence of Transient ischemic attack [ Time Frame: 12 months ]
  4. The incidence of Heart Failure [ Time Frame: 12 months ]
  5. The incidence of Atrial fibrillation or Flutter [ Time Frame: 12 months ]
  6. The incidence of Coronary artery revascularization [ Time Frame: 12 months ]
  7. The incidence of Hospitalization for worsening of PAD [ Time Frame: 12 months ]
  8. The incidence of Limb peripheral artery revascularization [ Time Frame: 12 months ]
  9. The incidence of Lower limb amputation for arterial vascular disease [ Time Frame: 12 months ]
  10. The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion) [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921905


Contacts
Layout table for location contacts
Contact: Marta Baviera, PharmD +390239014 ext 633 marta.baviera@marionegri.it

Locations
Layout table for location information
Italy
MEDICOOP Genova Not yet recruiting
Genova, GE, Italy, 16165
Contact: Pierclaudio Brasesco, MD    +393356593590    brasesco@fastwebnet.it   
Cooperativa Medici Milano Centro Recruiting
Milan, MI, Italy, 20154
Contact: Alberto Aronica, MD    +393356415072    albertoaronica@gmail.com   
MEDICOOP S. Agata Not yet recruiting
Reggio Calabria, RC, Italy, 89134
Contact: Giuseppe Galletta, MD    +393358204167    giuseppe.galletta@gmail.com   
ROMAMED Service Recruiting
Rome, RM, Italy, 00137
Contact: Antonio CALICCHIA, MD    +390688970 ext 322    dr_anto_17@hotmail.it   
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Layout table for investigator information
Study Director: Marta Baviera, PharmD Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Layout table for additonal information
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03921905     History of Changes
Other Study ID Numbers: IRFMN-7825
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Negri Institute for Pharmacological Research:
Peripheral Artery Disease
Coronary Artery Disease
General Practice
Ankle-brachial index (ABI)
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases