Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04312230 |
| Other study ID # |
ICC-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2017 |
| Est. completion date |
January 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Manchester University NHS Foundation Trust |
| Contact |
Christopher Miller, MBChB PhD |
| Phone |
0161 291 4560 |
| Email |
christopher.miller[@]manchester.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac
muscle, vasculature, or conductive system. These conditions sometimes present with sudden
cardiac death, and may have significant implications for families. Whilst their prevalence
may be rare, our understanding of these conditions has increased over the past decade. ICC
Clinics aim to improve the diagnosis, treatment and outcomes of these patients.
The NIH has defined a biomarker as "a characteristic that is objectively measured and
evaluated as an indicator of normal biological processes, pathogenic processes, or
pharmacologic responses to a therapeutic intervention". Biomarkers can indicate disease
characteristics, including markers of clinical disease, or indicators of therapeutic
response.
This study aims to investigate the utility of biomarkers in a large cohort of patients who
are attending the ICC clinic. Biomarkers will be related to the presence and severity of
cardiovascular disease and other markers of cardiac disease.
Description:
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac
muscle, vasculature, or conductive system. More than 50 ICCs have been recognised and our
diagnostic capabilities ever improve. However, whilst our understanding of ICCs and their
molecular basis has increased, management of these conditions remains challenging owing to
their heterogeneity, both genetically and clinically. ICC clinics aim to improve and
standardise the care of patients with ICCs but improving diagnosis, risk stratification, and
management, and by coordinating specialist care provided by other specialities. The UHSM ICC
clinic has recently been established, providing tertiary care for patients across a large
geographical area. As such, it is well placed is well placed to do this study.
Sudden cardiac death may be the first presentation of ICC, and a new diagnosis has
significant implications for families. Risk may be augmented by a multitude of clinical and
genetic factors, and there is an increasing need for tools that may be used by clinicians to
identify patients at increased risk. Biomarkers are one such tool which may be able to assist
in the complex identification of high-risk individuals, to effectively prognosticate and
monitor treatment patients with disease.
As part of this study, all patients due to attend the ICC at USHM will be approached over a 5
year period. The expectation is to recruit 750 patients. Patients will undergo their clinic
appointments in the usual manner. As part of the study, a peripheral blood sample of
approximately 10mL will be taken to allow measurement of cardiac biomarkers in order to
further characterise cardiovascular status and to relate clinical findings to other markers
of cardiac disease. Biomarker levels will be related to the presence and severity of
cardiovascular disease, at the time of the clinic visit and over subsequent 10 year
follow-up, as documented by validated health status questionnaires and information in
patients' medical records.
This is an observational study of patients referred clinically to the Inherited Cardiac
Conditions clinic at the University Hospital of South Manchester.
As part of this study, all patients referred to this clinic will be approached over a 5 year
period. The expectation is to recruit 150 patient per year.Patients will attend clinic and
other related clinically indicated appointments in the usual manner. As part of the study, a
blood sample of approximately 10mL will be taken from the patients arm to allow measurement
of cardiac biomarkers in order to further characterise cardiovascular status and to relate
these findings to other markers of cardiac disease.
The patient will also be asked to complete a questionnaire about their symptoms and quality
of life.
