CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs

Investigator(s): .....NUMELE si PRENUMELE (seria, grupa)........................................

Data set: ...Nr fisierului de date primit............................

Objectives: Primary: To evaluate the prevalence of Peripheral Arterial Disease

(PAD) in patients admitted in hospital with diagnosis of ACS or outpatients after an
ACS (within last 6 months), ambulatory checked. Secondary: To identify the Main
Clinical Variables associated with a higher risk of PAD among this population To
evaluate the therapeutic management of these patients To train Cardiologists to
measure Ankle / Brachial Index (ABI) in order to improve diagnosis of PAD

Methodology: open-label, non-randomized, national, multicentric, prospective,

noninterventional study

Number of patients/subjects: 100

Evaluated: ABI (Cut-off for PAD 0,9) Epidemiological data: atherothrombotic risk
factors cardiovascular previous events treatments prescribed at visit 1 (by
therapeutic class)

Diagnosis and criteria for inclusion: Inclusion Criteria: patients > 40 years
admitted in hospital with diagnosis of Acute Coronary Syndrome or outpatients after
an ACS (within last 6 months), ambulatory checked; informed consent signed
Exclusion Criteria: patients < 40 years; patients who did not sign the informed
consent form; patients enrolled in other studies

Criteria for evaluation: Will be collected: demographic data of the patient,

cardiovascular risk factors, personal history of cardiovascular diseases, clinical data,
diagnosis of coronary disease, Ankle-Brachial Index (ABI), antiplatelet treatment
recommended at baseline.

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Summary:

Population studied: patients, with the following gender distribution: %

male and % female and with mean age of years ( years in
male group, respective years in female one).

Cardiovascular risk factors Cardiovascular risk factors Count Column N %

Hypertension
No ........ % Yes ........ %
Diabetes mellitus
No ........ % Yes ........ %
Smoking / History of smoking
No ........ % Yes ........ %
Dyslipemia
No ........ % Yes ........ %
Family history of cardiovascular disease
No ........ % Yes ........ %

Personal history of cardiovascular disease of the patients ( %) were

having history of coronary disease (angina pectoris, myocardial infarction etc),
patients ( %) history of cerebrovascular disease (stroke, TIA, carotid stenosis
etc) and of them ( %) history of peripheral arterial disease.
Clinical data at baseline Mean weight was kg ( kg in the male group and
kg in the female one), mean height cm ( cm in the male group and
cm in the female one) and mean waist cm ( cm in the male group,
respective cm in the female one). Clinical data SBP DBP Heart rate
N
Valid ........ ........ ........ Missing ........ ........ ........ Mean value ........ ........ ........

Diagnosis of the coronary disease of the patients ( %) were diagnosed

with angina pectoris and of them ( %) with myocardial infarction. Mean
history of the disease was years.

Ankle-Brachial Index (ABI) measurement ABI measurement Frequency Percent

N
ABI 0.9 ........ % ABI < 0.9 ........ % Total ........ % Missing ........
% Total 100 100.0%

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Risk of major cardiovascular events based on ABI values ABI classification
Frequency Percent
N
ABI > 1.4 ........ % 1.4 ABI 0.9 ........ % ABI < 0.9 ........ % Total
........ % Missing ........ % Total 100 100.0%

Antiplatelet therapy recommended at baseline Therapeutic class Frequency Percent

Acetylsalicylic acid + Thienopyridine ........ % Thienopyridine ........ %
Acetylsalicylic acid ........ % Acetylsalicylic acid + Thienopyridine +
Others ........ % No treatment ........ % Thienopyridine + Others ........
%
Acetylsalicylic acid + Others ........ %
Others ........ % Total 100 100.0%
Major cardiovascular events occurred during the 6 months of follow up
Cardiovascular events Count Column N %
Vascular death
No ........ % Yes ........ %
Myocardial infarction
No ........ % Yes ........ %
Stroke / TIA
No ........ % Yes ........ %

% of the major cardiovascular events (vascular death, myocardial infarction and

stroke/TIA) occurred during the 6 months of follow up in the group of patients with
ABI values < 0.9 and only % in those with normal ABI values.

Conclusions:

The prevalence of Peripheral Arterial Disease (PAD) based on ABI measurement in

the cohort of 100 patients admitted to hospital with diagnostic of ACS or outpatients
after an ACS (within last 6 months), ambulatory checked was of %
( patients with ABI values < 0.9). ABI measurement is also considered as a
generalized atherosclerotic marker that may allow identifying patients at high risk
for developing cardio or cerebrovascular events: on top of the patients with ABI
values lower than 0.9 there were those ones with ABI values > 1.4 ( %)
indicating arterial stiffness and, as already mentioned, risk of major cardiovascular
events.

The main variables associated with a higher risk of PAD that have been identified
among this population were the following risk factors: hypertension, diabetes
mellitus, present smoking or history of smoking and history of cardiovascular
diseases (p values of statistical significance are illustrated below):

Risk factors Odds Ratio (95%CI)

Risk Ratio (95%CI) X2 uncorrected
X2 used
p-value
Hypertension ( - ) ( - ) ........ ........ Diabetes mellitus (
- ) ( - ) ........ ........ Smoking ( - ) ( - ) ........
........ Dyslipemia ( - ) ( - ) ........ ........ History CV disease
( - ) ( - ) ........ ........

The logistic regression calculation (taking into account all these risk factors
simultaneously) identified that hypertension, diabetes mellitus, present smoking or
history of smoking, dyslipemia as well as history of cardiovascular disease are all
risk factors with major impact on Peripheral Arterial Disease induction.

% of the major cardiovascular events (vascular death, myocardial infarction and

stroke/TIA) occurred during the 6 months of follow up in the group of patients with
ABI values < 0.9 and only % in those with normal ABI values.

% of the patients were on antiplatelet treatment at the inclusion visit: %

acetylsalicylic acid, % thienopyridine and % others, as monotherapy or in
combinations.

Date of report: ............. .- .- 2014......................................

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