Predictors of Atrial Fibrillation in Patients Undergoing Implantable Loop Recorder Implant

NCT04724889 | Unknown

• 1 other identifier: 254722
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Implantable Loop Recorders (ILR) are small devices the size of a memory stick, which are implanted to investigate stroke, palpitations and fainting episodes. They monitor the heart constantly and detect abnormalities such as slow or fast heart beats and an irregular heartbeat called Atrial Fibrillation (AF). Stroke is a life threatening condition and no cause is identified for over 30% of strokes. AF is a predominant risk factor for stroke. About 30% of patients with stroke are found to have AF when they are monitored with an ILR. Unfortunately not every patient with a stroke can have an ILR; one of the prohibiting factors is cost. Therefore, there is an urgent unmet clinical need to rationalise the use of ILRs and prioritise their implantation in those patients that have most to gain and therefore achieving cost-effectiveness and improving patient care. In order to achieve the above, identifying parameters that can predict the presence of underlying AF is very important. Studies have shown that special factors including patient's other medical problems, family history, factors on paper recording of the electrical activity of the heart, heart monitors and ultrasound scan of the heart can be useful in predicting AF. Also certain blood molecules have been investigated as potential predictors of AF. The aim of this study is to look at all the above factors and combine them in order to determine whether these factors can predict the presence of AF. Identify predictors of AF will allow doctors to identify patients at different risk of having AF and use the ILR in all possible patients that might need it.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (7)

• Medical comordbidities as potential predictors of AF in patients with and without stroke

  To determine whether medical conditions (such as hypertension, heart failure, asthma, cancer, sarcoidosis, hypothyroidism, hyperthyroidism, liver disease, kidney disease, ischaemic heart disease, pulmonary embolism, chronic obstructive pulmonary disease) are associated with AF in patients with and without stroke

  1 year

• Increased height and weight as potential predictors of AF in patients with and without stroke

  To determine whether increase height (in cm) and weight (in kg) are associated with AF

  1 year

• Smoking history (non smoker, ex smoker, current smoker) and increased alcohol intake as potential predictors of AF in patients with and without stroke

  To determine whether smoking history (non smoker vs ex smoker vs current smoker) and increased alcohol intake (\>14 units/ week) are associated with AF

  1 year

• Electrocardiographic variables as potential predictors of AF

  To determine whether PR and QRS duration, P wave duration, P wave dispersion, QTc duration, PW terminal force, QRS and p wave axis are associated with AF

  1 year

• Holter monitor variables as potential predictors of AF

  To determine whether number and percentage of atrial and ventricular ectopics, minimum, maximum and mean heart rate, heart rate variability and apnoea, hypopnea index are associated with AF

  1 year

• Echocardiographic variables as potential predictors of AF

  To determine whether increased left ventricular volume and dimensions, reduced left ventricular function assessed by ejection fraction and strain, increased left atrial volume and dimensions and reduced function (assessed using left atrial strain, emptying fraction and expansion index), increased right ventricular size and reduced function, increased right atrial area, presence of patent foramen ovale and presence of significant valve stenosis or regurgitation (moderate or severe) are associated with AF

  1 year

• Blood biomarkers as potential predictors of AF

  To determine whether existing blood biomarkers (haemoglobin, white cells, platelets, sodium, potassium, creatinine, thyroid function, lipid profile) are associated with AF

  1 year

Secondary Outcomes (1)

• High sensitivity troponin as a predictor of Atrial Fibrillation in patients with and without previous stroke

  1 year

Study Arms (2)

Patients with underlying AF

Patients that will have AF detected by ILR will be compared with patients without AF.

Diagnostic Test: blood test

Patients without AF

Patients that will have AF detected by ILR will be compared with patients without AF.

Diagnostic Test: blood test

Interventions

blood test DIAGNOSTIC_TEST

Blood test to check high sensitivity troponin. Additional blood biomarkers maybe added in light of new research

Patients with underlying AF; Patients without AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that have been referred for Implantable Loop Recorder.

You may qualify if:

• Male or Female, aged 18 years or above.
• Patients referred for ILR
• Patients without history of AF
• Able to give consent

You may not qualify if:

• Patients with history of AF
• Patients unable to give consent

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: January 26, 2021
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

GB (1)