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The First Jordanian PCI Registry: Events at 1 Year (JoPCR1)

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ClinicalTrials.gov Identifier: NCT01841346
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jordan Collaborating Cardiology Group

Brief Summary:
The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in consecutive patients who undergo stent implantation and angioplasty in Jordan.

Condition or disease Intervention/treatment
Percutaneous Coronary Intervention Procedure: Procedure: PCI

Detailed Description:
  1. Voluntary registry of consecutive patients undergoing Percutaneous coronary intervention (PCI).
  2. Patients will be treated according to the treating cardiologists' discretion. No randomization of any medication or stent.
  3. Baseline data on admission will be collected (cardiovascular risk factors, blood lipids, ect).
  4. PCI procedure details and complications will be documented during the index admission.
  5. Outcome events (death, MI, revascularization, stent thrombosis) will be evaluated at 1, 6, and 12 months by clinic visits or phone calls.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The First Jordanian Percutaneous Coronary Intervention (PCI) Registry
Study Start Date : March 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort Intervention/treatment
PCI patients
Patients undergoing PCI for elective or ACS will be enrolled.
Procedure: Procedure: PCI
Other Name: PCI (percutaneous coronary intervention)will be performed according to cardiologists discretion, with no randomization of stent types or medications.




Primary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 1 year ]
    All cases of deaths from cardiovascular causes will be counted at 1 year.


Secondary Outcome Measures :
  1. Admission for urgent coronary revascularization [ Time Frame: 1 year ]
    All events of hospital readmission for repeat coronary intervention for acute coronary syndrome from the time of discharge from hospital up to 1 year will be documented.


Other Outcome Measures:
  1. Stent thrombosis [ Time Frame: 1 year ]
    All cases of definite/probable/possible stent thrombosis will be documented from the time of stent implantation during the index admission to 1 year.

  2. Baseline risk factors and outcome after 1 year [ Time Frame: 1 year ]
    Several factors at baseline will be evaluated as potential contributors to adverse outcome after one year, including: age, gender, renal impairment, heart failure, CRUSADE bleeding risc score, GRACE risk score, diabetes, multiple risk factors, BMI, and smoking.

  3. Adherence to guidelines in patients undergoing PCI [ Time Frame: 1 year ]
    Using medications (statins, antiplatelets, ACI inhibitors/ARBs, B blockers, etc),and diagnostic and interventional procedures, and reaching target parameters (LDL cholesterol and HbA1c) according to the published guidelines will be evaluated.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with acute coronary syndrome and stable coronary syndromes undergoing PCI.
Criteria

Inclusion Criteria:

  • Consecutive PCI patients
  • Arab nationality

Exclusion Criteria:

  • less than 18 year of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841346


Locations
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Jordan
Istishari Hospital
Amman, Jordan, 11954
Sponsors and Collaborators
Jordan Collaborating Cardiology Group
AstraZeneca

Additional Information:

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Responsible Party: Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier: NCT01841346     History of Changes
Other Study ID Numbers: JoPCR1-12-12-12
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Jordan Collaborating Cardiology Group:
Outcome after PCI
Middle Eastern Patients