The Role of Biomarkers in Inherited Cardiac Conditions

NCT04312230 | Withdrawn

• 1 other identifier: ICC-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inherited Cardiac Conditions

Outcome Measures

Primary Outcomes (1)

• To establish to role of biomarkers in inherited cardiac conditions

  Biomarker profile of patients with cardiomyopathy. Describe the circulating biomarker characteristics of patients with cardiomyopathy, including troponin

  5 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 beapproached over a 5 year period. The expectation is to recruit 150 patient per year.

You may qualify if:

• Any adult patient attending the inherited cardiac conditions clinic

You may not qualify if:

• Age \< 16 years, Imprisonment Inability to provide informed consent.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

MFT

Manchester, M239QZ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Christopher Miller, MBChB PhD

  Manchester University NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 18, 2020
• Study Start: November 2, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

GB (1)