Utility of the Cardiac Electrical BiomarkerDisease

NCT03498105 | Unknown

• 1 other identifier: 16-MK-008
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations.

Conditions

Acute Chest Syndrome

Keywords

Acute Chest Syndrome

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CEB in detecting myocardial injury

  Metrics: sensitivity, specificity, PPV, NPV

  Day 1

Secondary Outcomes (4)

• Correlation between CEB and cardiovascular mortality

  30 days and 12 months

• Correlation between CEB and non-fatal myocardial infarction

  30 days and 12 months

• Correlation between CEB and readmission with progressive angina

  30 days and 12 months

• Relationship between CEB and need for revascularisation

  30 days and 12 months

Study Arms (6)

Emergency Department (ED)

450-500 participants who will; 1. self present to the Emergency Department (ED) will chest pain 2. be brought in by ambulance to ED with acute chest pain 3. be referred from Primary care or Urgent care centre with cardiac sounding chest pain

Community Cardiology Service (CCS)

This study group will consist of between 80-100 participants who self present to the Community Cardiology Service (CCS) in Milton Keynes primary care surgery

Participants with stable angina

This study group will consist of 450-500 participants with stable angina who have been referred for Stress Echocardiography.

Elective Coronary Angioplasty

This study group will consist of between 50-100 participants who will have been referred for elective coronary angioplasty

Cardio-toxic Chemotherapy

Consecutive patients being initiated on any of the following medication deemed as cardio toxic and requiring cardiac function will be approached to be recruited into the study.

Invasive Coronary Angiography

The dynamics and performance characteristics of the CEB during acute coronary occlusion in patients undergoing invasive coronary angiography.

Eligibility Criteria

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

Study Population

Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Male or Female, aged 18 years or above

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Unable or unwilling to give valid consent for participation in the study
• Participant has been previously recruited to another module of the VECTRA ECG study
• Participant has history of allergy to ECG electrode
• Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor
• ECG tracing with a wandering baseline
• Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy)
• QRS duration greater than 120 milliseconds
• Q waves (except positional Q waves checked by deep inspiration)
• Suspected Septicaemia, pulmonary embolism or aortic dissection
• Recent history of trauma to thorax
• Severe renal impairment with eGFR \<30 ml/min
• Acute chest pain assessment in the Primary Care Surgery
• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.

Sponsors & Collaborators

• Joanne Turner: lead

Study Sites (1)

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, Bucks, MK6 5LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Chest Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Attila kardos

  Milton Keynes University Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoanela Colda

CONTACT

0044 1908 995136; antoanela.colda@mkuh.nhs.uk

Joanne Turner

CONTACT

01908995136; joanne.turner@mkuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academic Research Coordinator

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: April 13, 2018
• Study Start: May 22, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)