CLINICAL STUDY REPORT Comment [EP1]: Arial,14,Bold, Centrat

Study Title Comment [EP2]: Arial,12,Bold, Centrat

Comment [EP3]: Arial 12, centrat,
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs Spacing before and After 12 pt

Investigator(s): .....NUMELE si PRENUMELE (seria, grupa)........................................ Comment [EP4]: Arial,12,Bold

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

Objectives:
Primary: Comment [EP5]: Arial,12,Bold
 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. Comment [EP6]: Arial, 11
Secondary:
 To identify the Main Clinical Variables associated with a higher risk of PAD among this Comment [EP7]: Paragraph:
population Indentation and Spacing: Indentation: Left:
0.63 cm, Special: Hanging, By: 0.63 cm
 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, non-

interventional 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. Comment [EP8]: Paragraph:
Indentation and Spacing: Indentation: Left:
0 cm, Special: First line, By: 1.25 cm
Summary:
Comment [EP9]: Arial,14,Bold
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). Comment [EP10]: Arial,11

Cardiovascular risk factors

Cardiovascular risk factors Count Column N % Comment [EP11]: Arial,11
Paragraph: Indentation and Spacing:
No ........ % Indentation: Left: 0.11 cm, Right: 0.11 cm,
Hypertension Special: None
Yes ........ % Spacing: Before: 3 pt, After: 3 pt, Line
spacing: Single
No ........ %
Diabetes mellitus
Yes ........ %
No ........ %
Smoking / History of smoking
Yes ........ %
No ........ %
Dyslipemia
Yes ........ %
No ........ %
Family history of cardiovascular disease
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
Valid ........ ........ ........
N
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
ABI ≥ 0.9 ........ %
N ABI < 0.9 ........ %
Total ........ %
Missing ........ %
Total 100 100.0%
Risk of major cardiovascular events based on ABI values
ABI classification Frequency Percent
ABI > 1.4 ........ %
1.4 ≥ ABI ≥ 0.9 ........ %
N
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 %
No ........ %
Vascular death
Yes ........ %
No ........ %
Myocardial infarction
Yes ........ %
No ........ %
Stroke / TIA
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 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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