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CTRI Number  CTRI/2024/03/063476 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on clinical presentation and the use of 72 hour Holter monitoring in acute ischemic stroke and Transient ischemic attack(TIA) patients 
Scientific Title of Study   A study on clinical profile and the utility of 72 hour Holter monitoring in acute ischemic stroke and Transient ischemic attack(TIA) patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR.P.SRI HARSHITHA  
Designation  NEUROLOGY,SENIOR RESIDENT  
Affiliation  KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA  
Address  Department of neurology Kasturba medical college Tiger circle road, Madhav Nagar Manipal Udupi district Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9573255457  
Fax    
Email  sriharshitha13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr NIKITH A. 
Designation  ASSOCIATE PROFESSOR,NEUROLOGY 
Affiliation  KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA  
Address  Department of neurology Kasturba medical college Tiger circle road, Madhav Nagar Manipal Udupi district Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9964667280  
Fax    
Email  dr.nikith@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr NIKITH A. 
Designation  ASSOCIATE PROFESSOR,NEUROLOGY 
Affiliation  KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA  
Address  Department of neurology Kasturba medical college Tiger circle road, Madhav Nagar Manipal Udupi district Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  9964667280  
Fax    
Email  dr.nikith@gmail.com  
 
Source of Monetary or Material Support  
Department of neurology kasturba medical college, manipal, udupi, karnataka 
 
Primary Sponsor  
Name  PSRI HARSHITHA  
Address  Kasturba hospital, Manipal, Udupi, karnataka  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR P Sri Harshitha   KASTURBA MEDICAL COLLEGE  Dhanvantari wards third floor,Bhaliga block, Department of neurology Tiger circle road, Madhav Nagar Manipal Mahe India
Udupi
KARNATAKA 
9573255457

Sriharshitha13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia, (2) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years

2. All patients with newly diagnosed (within 1 week of symptom onset)acute ischemic stroke and tia  
 
ExclusionCriteria 
Details  1. Patients with chronic infarct admitted with neurological
illness other than acute stroke
2. Patients with stroke due to other causes like
Hemmoraghic stroke
Trauma
Dissecting of aortic aneurysm
Infectious diseases like meningitis
3. Known case of atrial fibrillation on oral anticoagulants
4. Patients who are unable or unwilling to give informed
informed consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To describe the clinical profile and utility of 72 holter in detecting paroxysmal AF and other cardiac arrythmias in acute ischemic stroke and transient ischemic attack(TIA) patients   After 72 hrs of Holter monitoring in the patients 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the paroxysmal AF & other cardiac arrythmias predisposing to acute ischemic stroke or TIA   Holter reports analysed After 72 hours of Holter monitoring of the patients  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Stroke is a second leading cause of death worldwide that we frequently encounter in hospital setting which can be often preventable and a timely treatment can reduce its morbidity.

The risk factors for stroke are age, sex, smoking habits, hypertension, diabetes, atrial fibrillation/flutter.

Atrial fibrillation/flutter (AF), a strong risk factor for stroke and most important finding on cardiac workup in patients with ischemic stroke.

AF is associated with a high risk of cardio embolic stroke while thromboembolic complications bear an annual risk of 3–6%, which is 5 to 7 times greater than that of controls with sinus rhythm.

The association between cerebrovascular and cardiovascular diseases is mainly due to sharing of common risk factors.AF associated stroke occurred in one third of all patients and was associated with a distinct profile of recurrent, severe and disabling stroke.

The features of AF such as duration, episodic frequency, and asymptomatic presentation makes its detection challenging and elusive to bedside screening measures that includes pulse monitoring and routine ECG. 

Paroxysmal AF or subclinical AF is a self–terminating recurrent form of cardiac arrhythmia that present as a brief single episode of arrhythmia or cluster of abnormal rhythm of variable duration, sometimes evolving into more persistent and permanent form.

In clinical practice, infrequent prolonged ECG-monitoring might lead to under diagnosis of underlying atrial fibrillation and can lead to less effective treatment in prevention of stroke.

Several studies have explored the use of noninvasive and invasive cardiac monitoring devices to identify AF but with variable success.


Patients with subclinical AF leading may ensue hospitalization only with the evidence of sinus rhythm and thus, typically receive antiplatelet therapy which is inferior to anticoagulant therapy for clinically apparent AF. 

The occurrence of AF may be also be missed on bedside monitoring by routine ECG .Hence, use of holter can be advantageous in such cases to record all the events.

In a study conducted by  Kwon S et al , Compared to the 24-hour Holter test, AF detection could be improved with 72-hour single-lead ECG monitoring.

 In a study conducted by D Hughes and et al, the number of abnormal results that are detected after the initial 24 h period decreases significantly with only minimal arrhythmias detected on day 4 or 5. 
Therefore by limiting  holter monitoring  to 24–72 h, the amount of arrhythmias detected per day of recording would increase dramatically.

In a  prospective, multicenter study conducted by martin grond et al demonstrated that integrating a prolonged 72-hour ECG monitoring into a standardized diagnostic and therapeutic assessment protocol improves detection of previously undiagnosed AF in survivors of a stroke or TIA  can detect the AF which might be missed during bedside monitoring 

The 2016 Atrial Fibrillation guideline of the European Society of Cardiology recommends at least 72 h of Holter monitoring.Early detection of AF using this method is a cost effective approach for the burden of the disease.

However, atrial fibrillation might escape routine short term electrocardiogram (ECG)-monitoring if it occurs intermittently, because the episodes are often short, occur in irregular patterns, and are frequently asymptomatic.Prolonged ECG-monitoring is adequate, if underlying paroxysmal atrial fibrillation is suspected.

The detection of atrial fibrillation in patients with acute ischaemic stroke is of major clinical relevance,  because it usually shifts the secondary prevention therapy from antiplatelet drugs to oral anticoagulation.

Furthermore, 72-hour monitoring seems feasible in most healthcare settings because patients with stroke are usually managed as inpatients for at least three days, allowing implementation of the prolonged monitoring without changes in care pathways.

Atrial fibrillation-related strokes can be more severe than those from other causes and patients with stroke and atrial fibrillation have a high risk of recurrent ischaemic events.
Once identified introduction of oral anticoagulant therapy provides an additional 40% risk reduction in recurrent stroke compared with antiplatelet therapy.

Oral anticoagulation therapy leads to a 60–70% relative risk reduction of recurrent strokes in  those with atrial fibrillation, compared with placebo.

Further,recent evidence suggests that therapeutic oral anticoagulation (international normalized ratio 2 to 3) may also be associated with reduced stroke severity, if ischemic stroke does occur in patients with AF

Given that ischemic stroke with AF is associated with greater disability and mortality than those without AF, establishing the presence of underlying AF is of clear clinical importance.

Guidelines recommend that patients with atrial fibrillation should be given oral anticoagulants, irrespective of whether they have paroxysmal (defined as episodes of at least 30 s, but occurring for fewer than 7 days or persisting atrial fibrillation).









 
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