The First Jordanian PCI Registry: Events at 1 Year

Percutaneous Coronary Intervention Clinical Trial

— JoPCR1  

Official title:

The First Jordanian Percutaneous Coronary Intervention (PCI) Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841346
• Other study ID #: JoPCR1-12-12-12
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: January 7, 2017
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2017
• Source: Jordan Collaborating Cardiology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Consecutive PCI patients

• Arab nationality

Exclusion Criteria:

• less than 18 year of age

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Procedure:
• Procedure: PCI

Locations

Country	Name	City	State
Jordan	Istishari Hospital	Amman

Sponsors (2)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group	AstraZeneca

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stent thrombosis	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	No
Other	Baseline risk factors and outcome after 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	No
Other	Adherence to guidelines in patients undergoing PCI	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	No
Primary	Cardiovascular mortality	All cases of deaths from cardiovascular causes will be counted at 1 year.	1 year	No
Secondary	Admission for urgent coronary revascularization	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	No