| CTRI Number |
CTRI/2025/08/093518 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
disturbances in the electrical activity of heart its incidence and management in emergency department |
|
Scientific Title of Study
|
CARDIAC ARRYTHMIAS - Its incidence and management in Emergency Department |
| 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 Anmol kaur nagpal |
| Designation |
Junior resident 1 |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of emergency medicine, Acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha
Wardha MAHARASHTRA 442005 India |
| Phone |
8984410256 |
| Fax |
|
| Email |
Anmolnagpal70@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gajanan Chavan |
| Designation |
professor and Head of the Department |
| Affiliation |
Emergency Medicine Department, AVBRH, JNMC, DMIHER, Sawangi (Meghe), Wardha |
| Address |
Department of emergency medicine, Acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha Department of emergency medicine, Acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha Wardha MAHARASHTRA 442005 India |
| Phone |
8984410256 |
| Fax |
|
| Email |
gcgcny@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anmol kaur nagpal |
| Designation |
Junior resident 1 |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of emergency medicine, Acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha
Wardha MAHARASHTRA 442005 India |
| Phone |
8984410256 |
| Fax |
|
| Email |
Anmolnagpal70@gmail.com |
|
|
Source of Monetary or Material Support
|
| acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha, maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr. ANMOL KAUR NAGPAL |
| Address |
Acharya vinobha bhave rural hospital, jawaharlal nehru medical college, sawangi meghe, wardha, maharashtra |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anmol kaur nagpal |
Acharya vinobha bhave rural hospital |
Department of emergency medicine, acharya vinobha bhave rural hospital, sawangi meghe Wardha MAHARASHTRA |
8984410256
anmolnagpal70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adults (18 years and above) of all genders, who are willing to participate in the study, coming with the complaints of chest pain, palpitations, uneasiness, dyspnea |
|
| ExclusionCriteria |
| Details |
1-Signs of acute/chronic myocardial infarction on ECG
2-Presence of ventricular tachycardia/fibrillation
3-Vasovagal Bradyarrhythmia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-To estimate the prevalence of cardiac arrythmias and incidence of complications in 8 weeks
2-To determine the most common abnormal rhythm.
|
1-To estimate the prevalence of cardiac arrythmias and incidence of complications in 8 weeks
2-To determine the most common abnormal rhythm.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To determine association between gender, age & personal habits in 8 weeks
2-To determine the management of cardiac arrythmias in Emergency Department.
3-Outcome & Disposition of patients with cardiac arrythmias
|
management & disposition |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
13/10/2025 |
| 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="6" 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
|
purpose of the study - What is the frequency and diagnosis of Dysrhythmias in patients visiting to Emergency Department and what are the management practises for the same. summary- A few of the most distressful causes of heart malfunctions occur due to abnormal rhythmicity of the heart known as CARDIAC ARRYTHMIAS. They can be described as irregular rhythm of beating of the heart which can be either slower than normal (<60/min) or faster (>100/min) and can occur in any individual of any age. In it usually the electrical activity of the atria is not in co-ordination with the electrical beat activity of the ventricles. Hence the atria and SA Node have lost their ability of being the supreme primary pump as well as electric impulse generator. Symptoms pertaining because of cardiac arrythmias are commonly being presented to the emergency departments of the hospitals for evaluation and consultation in all age groups. The code "cardiac abnormalities", which include ‘Cardiac Arrythmias’, is assigned to individuals who complain of palpitations, dyspnea, pre-syncope/collapse, gastrointestinal symptoms, chest pain, uneasiness, tachycardia, or bradycardia. A differential diagnosis of the type of arrythmia is then established after analysis of the clinical presentation and heart rhythm in a 12-lead Electrocardiogram. Priorities for managing cardiac arrhythmias in the emergency department (ED) include- · Early recognition and triaging with management, · quick assessment of any potential hemodynamic instability, · finding and treating the inherent or precipitating cause, · a thorough evaluation of the patient’s medical history with special focus on the risk of thromboembolism. Cardiovascular arrhythmias are then primarily treated by ED doctors using either a rate-controlling or rhythm-controlling approach. Priority should be given to managing thromboembolism risks. Medical therapy includes administering pharmacological agents for rate control including Calcium blocker- verapamil, diltiazem, Beta blocker- metoprolol, adenosine, lignocaine and amiodarone as well as correcting electrolyte abnormalities like magnesium or potassium. Rhythm control approach for managing cardiac arrythmias are also being practised in ED either by use of drugs or by electrical cardioversion. Therefore, the purpose of this study is to estimate the prevalence of cardiac arrhythmias, their diagnosis, complication rate, management and outcomes in our tertiary care hospital’s emergency department. |