PGD2 Formation in Vascular Injury

Study Overview
=================
Brief Summary
-----------------
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.

Detailed Description
-----------------
A) To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans B) Patients will be grouped base on their aspirin using status. Three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Official Title
-----------------
Biosynthesis of PGD2 in Vascular Injury

Conditions
-----------------
Coronary Artery Disease, Acute Coronary Syndrome, Stable Angina

Intervention / Treatment
-----------------
* Drug: No ASA
* Drug: Low dose ASA
* Drug: 325 mg ASA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with existing CAD admitted for elective PTCA: Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or No aspirin therapy at all Patients presenting to the ER with Acute Coronary Syndrome(ACS)who will have a PTCA Patients with stable angina or positive stress tests scheduled for a cardiac catheterization Exclusion Criteria: History of unstable diabetes (hgb A1c>8 or FBS> 200) Uncontrolled hypertension (SBP > 180, DBP >100) History of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject. Patients who have taken NSAIDS or COX-2 inhibitors other than aspirin, for at least 10 days prior to PTCA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Aspirin Treatment<br> | Drug: No ASA<br>* Alternative antiplatelet therapy instead of aspirin<br>|
| 81 mg Aspirin Treatment<br> | Drug: Low dose ASA<br>* Low dose aspirin (81mg) prior to PTCA<br>|
| 325 mg Aspirin<br> | Drug: 325 mg ASA<br>* high dose of aspirin prior to PTCA<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite. |  | 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether aspirin could blunt the increment of PGD2 if there is. |  | 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostaglandins, vascular injury