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

January 7, 2017 updated by: Jordan Collaborating Cardiology Group

The First Jordanian Percutaneous Coronary Intervention (PCI) Registry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11954
        • Istishari Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with acute coronary syndrome and stable coronary syndromes undergoing PCI.

Description

Inclusion Criteria:

  • Consecutive PCI patients
  • Arab nationality

Exclusion Criteria:

  • less than 18 year of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1 year
All cases of deaths from cardiovascular causes will be counted at 1 year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan Collaborating Cardiology Group

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (ESTIMATE)

April 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 7, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JoPCR1-12-12-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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