The Utility of Cardiac CT in Excluding Ischemic Cardiomyopathy in Patients With Newly Diagnosed Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01622985
First received: June 15, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

HF may be classified into two main categories: ischemic, caused by the narrowing of the heart's arteries by cholesterol build up, also called coronary artery disease (CAD) and non-ischemic which is not caused by CAD. The narrowing of the blood vessel may be caused by the build up of calcium deposits. The ability to accurately categorize patients is very important in order to properly manage patients with HF.

The objective of this study is to determine the ability of CT in ruling out ischemic cardiomyopathy as the cause of newly diagnosed heart failure.

We will enroll patients with newly diagnosed heart failure (diagnosed within past 6 months) of unknown etiology. Patients will receive routine investigations (to determine the etiology of heart failure) at the discretion of their attending cardiologist. In addition, patients will undergo a low-dose non-contrast enhanced CT scan. These CT results will be compared to their final clinical diagnosis. An Agatson score of 0 will be used to rule out ischemia as the underlying etiology. The outcome measure will be the ability of CT to rule out ischemia as the cause of heart failure.


Condition Intervention
Heart Failure
Procedure: CT scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Utility of Cardiac CT in Excluding Ischemic Cardiomyopathy in Patients With Newly Diagnosed Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Coronary artery calcification (Agatston) score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The primary outcomes measure will be coronary artery calcification score (Agatston score = 0 (absence of coronary artery calcification) or Agatston Score > 0 (coronary artery calcification present). The hypothesis of the study is that an Agatston score = 0 rules out CAD as the cause of heart failure.


Estimated Enrollment: 370
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Newly diagnosed heart failure patients
Patients with newly diagnose (within 2 months) of congestive heart failure and/or left ventricular dysfunction in whom the etiology of heart failure/LV dysfunction is unknown.
Procedure: CT scan
One CT scan per patient

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All newly diagnosed patients with heart failure or left ventricular (LV) dysfunction in whom the etiology of heart failure/LV dysfunction is unknown.

Criteria

Inclusion Criteria:

  • Diagnosis of congestive heart failure and/or left ventricular dysfunction in whom the etiology of heart failure/LV dysfunction is unknown
  • Age 18 years or over

Exclusion Criteria:

  • Contraindication to radiation exposure (pregnancy)
  • Inability to perform breathhold > 20 seconds
  • Subjects with known allergies to either iodine or any iodine containing media
  • Subject has severe renal insufficiency (GFR <60)
  • Atrial fibrillation, frequent extra-systoles
  • Uncontrolled heart rate (HR >65 bpm)
  • Women who are breastfeeding
  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: NCT01622985

Contacts
Contact: Benjamin JW Chow, MD, FRCPC 613-761-4044 bchow@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Benjamin JW Chow, MD, FRCPC    613-761-4044    bchow@ottawaheart.ca   
Sub-Investigator: Haissam Haddad, MD, FRCPC         
Sub-Investigator: Lisa Mielniczuk, MD, FRCPC         
Sub-Investigator: Ronnen Maze, MD         
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Benjamin JW Chow, MD, FRCPC University of Ottawa Heart Institute
Study Chair: Haissam Haddad, MD, FRCPC University of Ottawa Heart Institute
Study Chair: Lisa Mielniczuk, MD, FRCPC University of Ottawa Heart Institute
Study Chair: Ronnen Maze, MD University of Ottawa Heart Institute
  More Information

Additional Information:
No publications provided

Responsible Party: University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01622985     History of Changes
Other Study ID Numbers: 20120079-01H
Study First Received: June 15, 2012
Last Updated: May 27, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa Heart Institute:
Agatston
Computed tomography
Coronary Artery Disease
Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014