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Early Post Transplant Cardiac Allograft Vasculopathy (ECAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03217786
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : May 14, 2020
Toronto General Hospital
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. CAV is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. Early detection of CAV is important as treatment options are poor once the disease is established. Currently, available techniques to evaluate CAV are limited by poor ability to detect disease early. The current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.

Condition or disease
Cardiac Allograft Vasculopathy

Detailed Description:
The objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of CAV. We will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. Heart transplant patients from the University of Ottawa Heart Institute and Toronto General Hospital will undergo a series of tests at 3 and 12 months after transplant. Statistical analyses will determine whether results from the above tests at 3 months predict the development of early CAV at 12 months after a heart transplant.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Early Post Transplant Cardiac Allograft Vasculopathy
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. CAV on invasive coronary studies [ Time Frame: 3 months and 1-year post-transplant. ]
    Changes in coronary intima on IVUS and OCT and invasive coronary flow

Secondary Outcome Measures :
  1. EMBx [ Time Frame: 3 months post-transplant ]
    Microvascular disease

  2. PET [ Time Frame: 3 months post-transplant ]
    Myocardial blood flow quantification

  3. Biomarkers [ Time Frame: 3 months post-transplant ]
    Serum biomarker panel

Biospecimen Retention:   Samples Without DNA
Specimens will be assessed for potential CAV biomarkers.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective longitudinal study will involve 2 Canadian adult heart transplant programs: University of Ottawa Heart Institute (UOHI, Ottawa) and University Health Network-Toronto General Hospital (UHN-TGH, Toronto).

Inclusion Criteria:

  1. Heart transplant <3 months.
  2. Age ≥18 years.
  3. Able and willing to provide informed consent.

Exclusion Criteria:

  1. Contraindications to dipyridamole.
  2. Contraindications to aminophylline.
  3. Contraindications to nitroglycerin.
  4. Contraindications to iodinated contrast.
  5. Acute allograft rejection ≤1 month.
  6. Uncontrolled heart failure or myocardial infarction ≤7 days.
  7. Estimated glomerular filtration rate ≤30 mL/min.
  8. Combined solid organ transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03217786

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Contact: Sharon Chih, MD, PhD 613-696-7000 ext 14869
Contact: Aun Yeong Chong, MD 613-696-7000 ext 14869

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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Sharon Chih    613-696-7327 ext 67339   
Contact: Aun Yeung Chong    613-696-7339 ext 67339   
Principal Investigator: Sharon Chih         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Toronto General Hospital
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Principal Investigator: Sharon Chih, MD, PhD Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation Identifier: NCT03217786    
Other Study ID Numbers: 0868
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
Macrovascular Disease
Microvascular Coronary Artery Disease
Cardiac Transplant Rejection
Transplant; Failure, Heart
Intravascular ultrasound (IVUS)
Optical Coherence Tomography
Index of Microcirculatory Resistance
Fractional Flow Reserve
Coronary Flow Reserve
Positron Emission Tomography
Endomyocardial Biopsies
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases