CLINICAL STUDY REPORT

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Study Title

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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.

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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

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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:
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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

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Count Column N %

Hypertension

Diabetes mellitus

Smoking / History of smoking

Dyslipemia

Family history of cardiovascular disease

No

........

Yes

........

No

........

Yes

........

No

........

Yes

........

No

........

Yes

........

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
Valid

........ ........

........

Missing

........ ........

........

Mean value

........ ........

........

Diagnosis of the coronary disease

of the patients (
%) were diagnosed with angina pectoris and
(
%) with myocardial infarction. Mean history of the disease was
Ankle-Brachial Index (ABI) measurement
ABI measurement Frequency Percent

ABI 0.9

........

ABI < 0.9

........

Total

........

........

Missing
Total

100 100.0%

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of them
years.

Risk of major cardiovascular events based on ABI values

ABI classification Frequency Percent
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

Myocardial infarction

Stroke / TIA

No

........

Yes

........

No

........

Yes

........

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)

X2

X2

uncorrected

used

Risk Ratio (95%CI)

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......................................

Comment [EP12]: p_value for used

test!

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