Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454045
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-15
Brief Title:
Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After an episode of acute ischemic syndrome patients with concomitant peripheral arterial disease have a worse short- and long-term prognosis compared to patients with isolated coronary disease but the mechanisms responsible are poorly understood In this population the presence of high platelet aggregability despite the use of antiplatelet drugs is related to a greater risk of future complications including heart attack and death from all causes
Thus the main objective of the present project is to evaluate the role of platelet aggregability analyzed by optical aggregometry using the AggRAM equipment in patients with a history of previous acute myocardial infarction with and without the presence of peripheral arterial disease Among the secondary objectives it is worth analyzing platelet aggregability in both groups using the Plateletworks method This is a case-control study with groups differentiated by the presence or absence of peripheral arterial disease matched by sex and age
It is expected that in the end relevant aspects related to platelet aggregation will be better characterized in this high cardiovascular risk population with a likely impact on new therapeutic strategies that can positively influence the morbidity and mortality of these patients
Thus the main objective of the present project is to evaluate the role of platelet aggregability analyzed by optical aggregometry using the AggRAM equipment in patients with a history of previous acute myocardial infarction with and without the presence of peripheral arterial disease Among the secondary objectives it is worth analyzing platelet aggregability in both groups using the Plateletworks method This is a case-control study with groups differentiated by the presence or absence of peripheral arterial disease matched by sex and age
It is expected that in the end relevant aspects related to platelet aggregation will be better characterized in this high cardiovascular risk population with a likely impact on new therapeutic strategies that can positively influence the morbidity and mortality of these patients
Detailed Description:
Polyvascular involvement is frequently present in atherosclerotic disease AD Lower Extremity Peripheral Artery Disease PAD represents one of the manifestations of AD it is estimated that around 47 of people with atherosclerotic disease have involvement in more than one vascular bed with coronary atherosclerotic disease and lower limb AD being the most prevalent
Initial studies suggest that platelet aggregability is increased in patients with PAD and the level of platelet aggregability is associated with the severity of PADHowever to our knowledge there are no studies in the literature analyzing platelet aggregability in patients with previous AMI with and without the concomitant presence of PAD which is the proposal of this research project
This study is an observational case-control study matched by sex and age Two groups will be selected Patients with previous infarction and isolated coronary involvement Group 1 Patients with previous AMI and concomitant presence of PAD of the lower limbs Group 2
Primary objective is compare platelet aggregability analyzed by optical aggregometry-ADP AggRAM- Helena Laboratories between the groups Secondary objetives includes laboratorial test of inflammation coagulation and subgroup analysis
Initial studies suggest that platelet aggregability is increased in patients with PAD and the level of platelet aggregability is associated with the severity of PADHowever to our knowledge there are no studies in the literature analyzing platelet aggregability in patients with previous AMI with and without the concomitant presence of PAD which is the proposal of this research project
This study is an observational case-control study matched by sex and age Two groups will be selected Patients with previous infarction and isolated coronary involvement Group 1 Patients with previous AMI and concomitant presence of PAD of the lower limbs Group 2
Primary objective is compare platelet aggregability analyzed by optical aggregometry-ADP AggRAM- Helena Laboratories between the groups Secondary objetives includes laboratorial test of inflammation coagulation and subgroup analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None