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CLINICAL STUDY REPORT

Study Title
PREvalence of peripheral arterial disease in acute coronary Syndrome patiENTs
Investigator(s): Cri Georgiana (seria VI, grupa 73)
Data set: 6079
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.





Summary:
Population studied: 100 patients, with the following gender distribution: 68% male and 32%
female and with mean age of 64,79 years (63,65 years in male group, respective 66,59 years in
female one).
Cardiovascular risk factors
Cardiovascular risk factors Count Column N %
Hypertension
No 15 15%
Yes 85 85%
Diabetes mellitus
No 62 62%
Yes 38 38%
Smoking/History of smoking
No 35 35%
Yes 65 65%
Dyslipemia
No 19 19%
Yes 81 81%
Family history of cardiovascular disease
No 42 42%
Yes 58 58%

Personal history of cardiovascular disease
79 of the patients (79 %) were having history of coronary disease (angina pectoris,
myocardial infarction etc), 20 patients ( 20 % ) history of cerebrovascular disease ( stroke,
TIA, carotid stenosis etc) and 33 of them ( 33 %) history of peripheral arterial disease.
Clinical data at baseline
Mean weight was 85,68 kg (90,68 kg in the male group and 75,06 kg in the female one), mean
Height 170,15 cm ( 174,26 cm in the male group and 161,41cm in the female one) and mean
waist 98,15 cm ( 99,83 cm in the male group, respective 94,43 cm in the female one).
Clinical data SBP DBP Heart rate
N
Valid 99 99 99
Missing 1 1 1
Mean value 145.83 84.96 75.45

Diagnosis of the coronary disease
65 of the patients ( 65 % ) were diagnosed with angina pectoris and 2 of them( 2 %) with
myocardial infarction. Mean history of the disease was 2,9 years.



Ankle-Brachial Index (ABI) measurement
ABI
measurement
Frequency Percent
N
ABI 0.9 34 34%
ABI<0.9 65 65%
Total 99 99%
Missing 1 1%
Total 100 100.0%

Risk of major cardiovascular events based on ABI values
ABI classification Frequency Percent
N
AB> 1.4 0 0 %
1.4 ABI 0.9 34 34%
ABI<0.9 65 65%
Total 99 99%
Missing 1 1%
Total 100 100.0%

Antiplatelet therapy recommended at baseline
Therapeutic class Frequency Percent
Acetylsalicylic acid +
Thienopyridine
60 60%
Thienopyridine 25 25%
Acetylsalicylic acid 10 10%
Acetylsalicylic acid +
Thienopyridine + Others
2 2%
No treatment 1 1%
Thienopyridine + Others 2 2%
Acetylsalicylic acid + Others 0 0%
Others 0 0%
Total 100 100.0%


Major cardiovascular events occurred during the 6 months of follow up
Cardiovascular events Count Column N
%
Vascular death No 99 99%
Yes 1 1%
Myocardial infarction No 98 98%
Yes 2 2%
Stoke/TIA No 100 100%
Yes 0 0%

66,66% 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 33,33% 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 93,9% ( 31 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 ( 0 %)
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 ris 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%Cl) Risk Ratio(95%Cl)
X
2

uncorrected
X
2

used
p-value
Hypertension 0,42(0,11-1,63) 0,78(0,58-1,06) 1,6130 0,9504 0,07
Diabetes
mellitus
1,48(0,62-3,55) 1,14(0,86-1,51) 0,7964 0,4554 0,57
Smoking 1,21(0,51-2,86) 1,00(0,78-1,45) 0,1882 0,0451 0,46
Dyslipemia 1,14(0,40-3,24) 1,04(0,71-1,52) 0,0651 0,0002 0,34
History CV
disease
1,33(0,57-3,07) 1,10(0.62-1,48) 0,4554 0,2122 0,52

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.
93,9% 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
6,1% in those with normal ABI values.

99% of the patients were on antiplatelet treatment at the inclusion visit: 70% acetylsalicylic
acid, 85% thienopyridine and 4% others, as monotherapy or in combinations.


Date of report: 04-25-2014















































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Evolutia greutatii,inaltimii si taliei in functie de sex
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Evolutia tensiunilor arteriale sistolice si diastolice in functie de varsta
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TAD