Heart TIMING - Heart Transplantation IMagING | NCT03499197

Studies
Heart TIMING - Heart Transplantation IMagING

NCT03499197

Sponsor

Semmelweis University Heart and Vascular Center

Status

Unknown status

Last Update Posted

Apr 17, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Heart Transplant Failure and Rejection
Magnetic Resonance Imaging

Interventions

cardiac magnetic resonance imaging

Countries

Hungary

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 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Jan 15, 2021Estimated

Completion Date

Jan 15, 2026Estimated

First Submitted Date

Apr 11, 2018

First Submission Date that Met QC Criteria

Apr 13, 2018

First Posted Date

Apr 17, 2018Actual

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 13, 2018

Last Update Posted Date

Apr 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hajnalka Vágó MD PhD, MD PhD, Associate Professor, Semmelweis University Heart and Vascular CenterPrincipal Investigator

Lead Sponsor

Semmelweis University Heart and Vascular CenterOTHER

Collaborators

Name	Class
National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017	UNKNOWN

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

The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

Detailed Description

12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
Endomyocardial biopsy
Detailed transthoracic echocardiography including strain analysis and 3D measurement
Detailed cardiac magnetic resonance (CMR) examination
Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac magnetic resonance imaging	Diagnostic Test	Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary allograft vasculopathy	Coronary allograft vasculopathy confirmed based on IVUS/OCT	5 years
Coronary allograft rejection	Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First heart transplantation

Exclusion Criteria:

Cardiogenic shock on/after day 28 after heart transplantation
Lack of consent
Lack of cooperation

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

Patients who underwent first cardiac transplantation.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hajnalka Vago, MD, PhD	Contact	+3620 8258058		vagoha@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart and Vascular Center, Semmelweis University	Recruiting	Budapest			Hungary

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012059	Rejection, Psychology

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided