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

June 15, 2012
May 27, 2014
May 2012
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01622985 on ClinicalTrials.gov Archive Site
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The Utility of Cardiac CT in Excluding Ischemic Cardiomyopathy in Patients With Newly Diagnosed Heart Failure
The Utility of Cardiac CT in Excluding Ischemic Cardiomyopathy in Patients With Newly Diagnosed Heart Failure

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Heart Failure
Procedure: CT scan
One CT scan per patient
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.
Intervention: Procedure: CT scan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
370
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Benjamin JW Chow, MD, FRCPC 613-761-4044 bchow@ottawaheart.ca
Canada
 
NCT01622985
20120079-01H
No
University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
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
University of Ottawa Heart Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP