Early Post Transplant Cardiac Allograft Vasculopathy | NCT03217786

Studies
Early Post Transplant Cardiac Allograft Vasculopathy

NCT03217786

Sponsor

Ottawa Heart Institute Research Corporation

Status

Active, not recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Cardiac Allograft Vasculopathy

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2018Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Dec 2026Estimated

First Submitted Date

Jul 11, 2017

First Submission Date that Met QC Criteria

Jul 11, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

Apr 30, 2026Actual

Name	Class
Toronto General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

Conditions

Cardiac Allograft Vasculopathy

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CAV on invasive coronary studies	Changes in coronary intima on IVUS and OCT and invasive coronary flow	3 months and 1-year post-transplant.

Secondary Outcomes

Measure	Description	Time Frame
EMBx	Microvascular disease	3 months post-transplant
PET	Myocardial blood flow quantification	3 months post-transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Chih, MD, PhD	Ottawa Heart Institute Research Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ottawa Heart Institute		Ottawa	Ontario	K1Y4W7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37999656	Derived	Chih S, Tavoosi A, Nair V, Chong AY, Dzavik V, Aleksova N, So DY, deKemp RA, Amara I, Wells GA, Bernick J, Overgaard CB, Celiker-Guler E, Mielniczuk LM, Stadnick E, McGuinty C, Ross HJ, Beanlands RSB. Cardiac PET Myocardial Blood Flow Quantification Assessment of Early Cardiac Allograft Vasculopathy. JACC Cardiovasc Imaging. 2024 Jun;17(6):642-655. doi: 10.1016/j.jcmg.2023.10.003. Epub 2023 Nov 22.
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