Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04274712
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-02-15
Brief Title:
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients
Sponsor:
Myway Gentics Srl
Organization:
Myway Gentics Srl
Study Overview
Official Title:
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients a Pilot Retrospective Study
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INNOGRAFTRS001
Brief Summary:
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the period 2016- 2019
Detailed Description:
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based surveillance during the period 2016- 2019
1 Primary end-point
To evaluate specificity and sensitivity of INNOGRAFT Heart Suite in identifying transplant rejection using blood samples collected from heart transplanted patients during the same day of endomyocardial biopsy EMB using the histological study of EMB specimen as reference technique
We will evaluate
1 Presence of rejection YesNo
2 Correct classification of rejection according to ISHLT 2004 guidelines Rejection will be considered Yes if ISHLT 2004 grading is 1R We chose ISHLT scale because it has been previously used in studies aimed at sensitivity assessment of other techniques Deng et al 2006 and because changes of therapeutic protocol are usually considered in presence of rejection grade higher than 2R
2 Secondary end-points
To evaluate the accuracy of INNOGRAFT Heart Suite in discriminating between the classes of rejection according to ISHLT 2004 guidelines using histological study of heart samples from EMB as reference technique
To look for potential clinical modifiers of cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite for every given rejection class Expected modifiers are inflammatory states not related to rejection and infections We will also consider the influence of other factors such as gender age pregnancy comorbidities such as other organ failure diabetes cancer
To find if a correlation between basal donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and clinical outcomes exists Clinical outcome considered will be rejection arrythmias graft failure hospitalization death
To find if a correlation between donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and parameters of cardiac function obtained through right heart catheterization exists Cardiac catheterization will measure cardiac index left atrium wedge right ventricle pressure pulmonary artery avarage pressure
To find if a correlation between donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and blood levels of calcineurin inhibitorproliferation inhibitor in therapeutic rangeoutside therapeutic range exists in each patient and between patients Calcineurin inhibitor proliferation inhibitor and steroids are routine therapy for patients who underwent heart transplant Blood levels are routinely measured in patient treated with calcineurin inhibitor or proliferation inhibitor protocols The aim is to identify through cfDNA measure the correct patient-specific level of immunosuppression
To find if differences in basal donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance between rATG-treated and rATG-untreated patients exist rATG is intended as induction therapy protocol before heart transplant
1 Primary end-point
To evaluate specificity and sensitivity of INNOGRAFT Heart Suite in identifying transplant rejection using blood samples collected from heart transplanted patients during the same day of endomyocardial biopsy EMB using the histological study of EMB specimen as reference technique
We will evaluate
1 Presence of rejection YesNo
2 Correct classification of rejection according to ISHLT 2004 guidelines Rejection will be considered Yes if ISHLT 2004 grading is 1R We chose ISHLT scale because it has been previously used in studies aimed at sensitivity assessment of other techniques Deng et al 2006 and because changes of therapeutic protocol are usually considered in presence of rejection grade higher than 2R
2 Secondary end-points
To evaluate the accuracy of INNOGRAFT Heart Suite in discriminating between the classes of rejection according to ISHLT 2004 guidelines using histological study of heart samples from EMB as reference technique
To look for potential clinical modifiers of cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite for every given rejection class Expected modifiers are inflammatory states not related to rejection and infections We will also consider the influence of other factors such as gender age pregnancy comorbidities such as other organ failure diabetes cancer
To find if a correlation between basal donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and clinical outcomes exists Clinical outcome considered will be rejection arrythmias graft failure hospitalization death
To find if a correlation between donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and parameters of cardiac function obtained through right heart catheterization exists Cardiac catheterization will measure cardiac index left atrium wedge right ventricle pressure pulmonary artery avarage pressure
To find if a correlation between donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance and blood levels of calcineurin inhibitorproliferation inhibitor in therapeutic rangeoutside therapeutic range exists in each patient and between patients Calcineurin inhibitor proliferation inhibitor and steroids are routine therapy for patients who underwent heart transplant Blood levels are routinely measured in patient treated with calcineurin inhibitor or proliferation inhibitor protocols The aim is to identify through cfDNA measure the correct patient-specific level of immunosuppression
To find if differences in basal donor cfDNA levels as quantitatively determined through INNOGRAFT Heart Suite on blood samples routinely collected for surveillance or symptoms-based surveillance between rATG-treated and rATG-untreated patients exist rATG is intended as induction therapy protocol before heart transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None