Arrhythmias, CardiacNCT06103305
Risk Stratifications for Patients With Palpitations
An observational study of Arrhythmias, Cardiac, run by Assiut University.
Trial summary
the aim of the study is to early diagnose and early proper mangment of those patients who have palpitations specially of cardiac origin Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients from 18 years old to 80 years old come to emergency department with palpitations
Who may be able to join
- The present study will be conducted on patients with Palpitations "without intently selected certain gender" and had 18 years old or more
Who cannot join
- patients refusing study will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Risk Stratifications for Patients Come With Palpitations in Assiut and Suez Canal University Hospitals
the aim of the study is to early diagnose and early proper mangment of those patients who have palpitations specially of cardiac origin
Read the detailed description
Palpitation : are one of the most common presentations to general practice, and while they are usually benign, they may also have life-threatening significance. Palpitations have been estimated to account for 16% of general practice presentations and are the second most common presentation to cardiologists after chest pain.
- Conditions
- Arrhythmias, Cardiac
- Keywords
- palpitations
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality during 30 days follow up
Measured: 30 days
Secondary outcomes (2)
Hospital admission
Admission to hospital from the Emergency Department
Measured: 0 days
ICU admission
Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startOct 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Zakaria Farah Tawdros, Assiut University
- Investigators
- Ragaa Ahmed Herdan, professor, Study director, Assiut UniversityMonira Taha ismail, professor, Study director, Suez Canal UniversityHany El moraba, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103305
- Sponsor's protocol ID
- palpitations
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giada F, Inama G, Bertaglia M, Pedrinazzi C, Gulizia M, Ricci R, Raviele A; Associazione Italiana di Aritmologia e Cardiostimolazione. [Management of patients with palpitations. Consensus document of the AIAC (Italian Association of Arrhythmiology and Cardiostimulation]. G Ital Cardiol (Rome). 2010 Apr;11(4):329-40. No abstract available. Italian.
PubMed 20677582Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1.
PubMed 24698469Weber BE, Kapoor WN. Evaluation and outcomes of patients with palpitations. Am J Med. 1996 Feb;100(2):138-48. doi: 10.1016/s0002-9343(97)89451-x.
PubMed 8629647Lessmeier TJ, Gamperling D, Johnson-Liddon V, Fromm BS, Steinman RT, Meissner MD, Lehmann MH. Unrecognized paroxysmal supraventricular tachycardia. Potential for misdiagnosis as panic disorder. Arch Intern Med. 1997 Mar 10;157(5):537-43.
PubMed 9066458Porter MJ, Morton JB, Denman R, Lin AC, Tierney S, Santucci PA, Cai JJ, Madsen N, Wilber DJ. Influence of age and gender on the mechanism of supraventricular tachycardia. Heart Rhythm. 2004 Oct;1(4):393-6. doi: 10.1016/j.hrthm.2004.05.007.
PubMed 15851189Gale CP, Camm AJ. Assessment of palpitations. BMJ. 2016 Jan 6;352:h5649. doi: 10.1136/bmj.h5649. No abstract available.
PubMed 26739319Dixit S, Stein PK, Dewland TA, Dukes JW, Vittinghoff E, Heckbert SR, Marcus GM. Consumption of Caffeinated Products and Cardiac Ectopy. J Am Heart Assoc. 2016 Jan 26;5(1):e002503. doi: 10.1161/JAHA.115.002503.
PubMed 26813889Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available.
PubMed 17041126Reddy RK, Pooni R, Zaharieva DP, Senf B, El Youssef J, Dassau E, Doyle Iii FJ, Clements MA, Rickels MR, Patton SR, Castle JR, Riddell MC, Jacobs PG. Accuracy of Wrist-Worn Activity Monitors During Common Daily Physical Activities and Types of Structured Exercise: Evaluation Study. JMIR Mhealth Uhealth. 2018 Dec 10;6(12):e10338. doi: 10.2196/10338.
PubMed 30530451Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available.
PubMed 21697315Thavendiranathan P, Bagai A, Khoo C, Dorian P, Choudhry NK. Does this patient with palpitations have a cardiac arrhythmia? JAMA. 2009 Nov 18;302(19):2135-43. doi: 10.1001/jama.2009.1673.
PubMed 19920238Voskoboinik A, Prabhu S, Ling LH, Kalman JM, Kistler PM. Alcohol and Atrial Fibrillation: A Sobering Review. J Am Coll Cardiol. 2016 Dec 13;68(23):2567-2576. doi: 10.1016/j.jacc.2016.08.074.
PubMed 27931615Flannery MD, Kalman JM, Sanders P, La Gerche A. State of the Art Review: Atrial Fibrillation in Athletes. Heart Lung Circ. 2017 Sep;26(9):983-989. doi: 10.1016/j.hlc.2017.05.132. Epub 2017 Jun 3.
PubMed 28606607Flaker GC, Belew K, Beckman K, Vidaillet H, Kron J, Safford R, Mickel M, Barrell P; AFFIRM Investigators. Asymptomatic atrial fibrillation: demographic features and prognostic information from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Apr;149(4):657-63. doi: 10.1016/j.ahj.2004.06.032.
PubMed 15990749Blomstrom-Lundqvist C, Scheinman MM, Aliot EM, Alpert JS, Calkins H, Camm AJ, Campbell WB, Haines DE, Kuck KH, Lerman BB, Miller DD, Shaeffer CW Jr, Stevenson WG, Tomaselli GF, Antman EM, Smith SC Jr, Alpert JS, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Hiratzka LF, Hunt SA, Jacobs AK, Russell RO Jr, Priori SG, Blanc JJ, Budaj A, Burgos EF, Cowie M, Deckers JW, Garcia MA, Klein WW, Lekakis J, Lindahl B, Mazzotta G, Morais JC, Oto A, Smiseth O, Trappe HJ; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines. Writing Committee to Develop Guidelines for the Management of Patients With Supraventricular Arrhythmias. ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Supraventricular Arrhythmias). Circulation. 2003 Oct 14;108(15):1871-909. doi: 10.1161/01.CIR.0000091380.04100.84. No abstract available.
PubMed 14557344
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratifications for Patients Come With Palpitations in Assiut and Suez Canal University Hospitals
- ClinicalTrials.gov ID
- NCT06103305
- Acronym / sponsor ID
- palpitations
- Conditions
- Arrhythmias, Cardiac
- Keywords
- palpitations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the aim of the study is to early diagnose and early proper mangment of those patients who have palpitations specially of cardiac origin
Detailed description
Palpitation : are one of the most common presentations to general practice, and while they are usually benign, they may also have life-threatening significance. Palpitations have been estimated to account for 16% of general practice presentations and are the second most common presentation to cardiologists after chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients from 18 years old to 80 years old come to emergency department with palpitations
Key inclusion criteria (1 listed)
- The present study will be conducted on patients with Palpitations "without intently selected certain gender" and had 18 years old or more
Key exclusion criteria (1 listed)
- patients refusing study will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
Mortality during 30 days follow up
2 secondary outcomes
Hospital admission
Time frame: 0 days
ICU admission
Time frame: 0 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 20677582Giada F, Inama G, Bertaglia M, Pedrinazzi C, Gulizia M, Ricci R, Raviele A; Associazione Italiana di Aritmologia e Cardiostimolazione. [Management of patients with palpitations. Consensus document of the AIAC (Italian Association of Arrhythmiology and Cardiostimulation]. G Ital Cardiol (Rome). 2010 Apr;11(4):329-40. No abstract available. Italian.
- Background: PubMed 24698469Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1.
- Background: PubMed 8629647Weber BE, Kapoor WN. Evaluation and outcomes of patients with palpitations. Am J Med. 1996 Feb;100(2):138-48. doi: 10.1016/s0002-9343(97)89451-x.
- Background: PubMed 9066458Lessmeier TJ, Gamperling D, Johnson-Liddon V, Fromm BS, Steinman RT, Meissner MD, Lehmann MH. Unrecognized paroxysmal supraventricular tachycardia. Potential for misdiagnosis as panic disorder. Arch Intern Med. 1997 Mar 10;157(5):537-43.
- Background: PubMed 15851189Porter MJ, Morton JB, Denman R, Lin AC, Tierney S, Santucci PA, Cai JJ, Madsen N, Wilber DJ. Influence of age and gender on the mechanism of supraventricular tachycardia. Heart Rhythm. 2004 Oct;1(4):393-6. doi: 10.1016/j.hrthm.2004.05.007.
- Background: PubMed 26739319Gale CP, Camm AJ. Assessment of palpitations. BMJ. 2016 Jan 6;352:h5649. doi: 10.1136/bmj.h5649. No abstract available.
- Background: PubMed 26813889Dixit S, Stein PK, Dewland TA, Dukes JW, Vittinghoff E, Heckbert SR, Marcus GM. Consumption of Caffeinated Products and Cardiac Ectopy. J Am Heart Assoc. 2016 Jan 26;5(1):e002503. doi: 10.1161/JAHA.115.002503.
- Background: PubMed 17041126Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available.
- Background: PubMed 30530451Reddy RK, Pooni R, Zaharieva DP, Senf B, El Youssef J, Dassau E, Doyle Iii FJ, Clements MA, Rickels MR, Patton SR, Castle JR, Riddell MC, Jacobs PG. Accuracy of Wrist-Worn Activity Monitors During Common Daily Physical Activities and Types of Structured Exercise: Evaluation Study. JMIR Mhealth Uhealth. 2018 Dec 10;6(12):e10338. doi: 10.2196/10338.
- Background: PubMed 21697315Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available.
- Background: PubMed 19920238Thavendiranathan P, Bagai A, Khoo C, Dorian P, Choudhry NK. Does this patient with palpitations have a cardiac arrhythmia? JAMA. 2009 Nov 18;302(19):2135-43. doi: 10.1001/jama.2009.1673.
- Background: PubMed 27931615Voskoboinik A, Prabhu S, Ling LH, Kalman JM, Kistler PM. Alcohol and Atrial Fibrillation: A Sobering Review. J Am Coll Cardiol. 2016 Dec 13;68(23):2567-2576. doi: 10.1016/j.jacc.2016.08.074.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragaa Ahmed Herdan, professor study director
Assiut University
Monira Taha ismail, professor study director
Suez Canal University
Hany El moraba, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Farah tawdros, Master (+201208727713, zakariamena3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103305, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.