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A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome (ICON1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01933581
First received: August 28, 2013
Last updated: August 31, 2013
Last verified: August 2013
  Purpose

Coronary artery disease and heart attacks are the leading cause of death in the UK. Our population is ageing. The number of older patients suffering heart attacks and having angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty, older patients (80 years of age or over) are at 5 times increased risk of death at one year compared to their predicted normal life expectancy. In addition, many patients present with further heart attacks, stroke and undergo repeat heart catheter test and angioplasty procedures. At present it is not clear who will or will not experience further problems in the future. The ability to predict who will and will not suffer future problems at the time of initial presentation can be helpful in providing additional treatment and close monitoring to those that are at risk of further problems. The ICON 1 study is set out to study just that. In this study, older patients will undergo a comprehensive evaluation of the cardiovascular disease burden by undergoing additional investigations. These results from each patient will be used to develop a risk score that will inform physicians of the patient's future risk of developing adverse events and provide a better understanding of how to manage older patients with coronary artery disease and also help plan future studies looking at treatment strategies that might be beneficial in improving outcomes.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ICON1: A Study to Improve Cardiovascular Outcomes in High Risk PatieNts With Acute Coronary Syndrome

Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Composite outcome: occurrence of one or more of death, myocardial infarction, stroke, repeat revascularisation, Bleeding Academic Research Consortium (BARC) defined bleeding [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life SF 36, EQ 5D [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ACS undergoing CA and PCI
Patients with Acute Coronary Syndrome undergoing coronary angiography and PCI

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ICON 1 is a prospective cohort study of older patients presenting with ACS.

Criteria

Inclusion criteria: Older patients (65+) presenting with ACS for coronary angiography will be recruited into this study.

Exclusion criteria: Those presenting with cardiogenic shock, those with co-existing malignancy with life expectancy less than one year and those with evidence of active infection such as urinary tract infection, pneumonia, sepsis and any wound infection will also be excluded from the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933581

Contacts
Contact: Vijay Kunadian, MD FRCP 00441912225797 vijay.kunadian@newcastle.ac.uk

Locations
United Kingdom
Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE77DN
Contact: Vijay Kunadian, MD FRCP         
Principal Investigator: Vijay Kunadian, MD FRCP         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: Vijay Kunadian, MD FRCP Newcastle University and NUTH NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01933581     History of Changes
Other Study ID Numbers: 12742
Study First Received: August 28, 2013
Last Updated: August 31, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014