Atrial FibrillationNCT05082558
Clinical Characteristics and Prognostic Factors of Atrial Fibrillation at a Tertiary Center of Pakistan - From a South-Asian Lens - a Retrospective Study.
An observational study of Atrial Fibrillation, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
To evaluate the clinical characteristics and management purseued for atrial fibrillation in a tertiary care center of Pakistan. We aimed at looking baseline characteristics and associated co-morbid conditions and primary diagnosis associated with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 651 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2018to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We reviewed hospital record files of 651 patients including both males and females, admitted in Aga Khan University Hospital from 1st July 2018 to 31st December 2018, who were found to have atrial fibrillation as a primary or associated diagnosis. Diagnosis of atrial fibrillation was confirmed on a 12 lead ECG.
Who may be able to join
- inpatients
- Age >/= 18 years
- Having atrial fibrillation on 12 lead surface EKG.
- Both males and females.
Who cannot join
- Age <18 years.
- Non-availability of 12 lead EKG.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the clinical characteristics and management purseued for atrial fibrillation in a tertiary care center of Pakistan. We aimed at looking baseline characteristics and associated co-morbid conditions and primary diagnosis associated with atrial fibrillation.
Read the detailed description
It is a retrospective observational study done at Aga Khan University Hospital, Karachi, Pakistan, which is a tertiary care teaching hospital with a cardiology and cardiac surgery center. Aga Khan Hospital is one of the main referral health centers in Pakistan.
This study was approved by Aga Khan University ethical review committee (ERC No. # 2019-1008-2905).We reviewed hospital record files of 651 patients including both males and females, admitted in Aga Khan University Hospital from 1st July 2018 to 31st December 2018, who were found to have atrial fibrillation as a primary or associated diagnosis. Diagnosis of atrial fibrillation was confirmed on a 12 lead ECG. Fifteen patients were excluded who did not have electrocardiographic evidence of atrial fibrillation.
For all patient, demographic information including age and gender, reason of admission and duration of arrhythmia were noted from the written medical records. Comorbidities were tabulated including: diabetes mellitus, hypertension, coronary artery disease, heart failure, cardiomyopathy, valvular heart disease, chronic obstructive pulmonary disease, and hyperthyroidism. Echocardiographic data were reviewed for left atrial (LA) dimension, LA volume index and left ventricular (LV) systolic function.
Patients were labeled as Diabetic if they had HbA1c of >6.5gm/dl or they were already on treatment for diabetes mellitus. Hypertension was defined as average of two readings of systolic blood pressure of ≥140mmHg or diastolic blood pressure of ≥90mmHg or patients already taking antihypertensive medications. Coronary artery disease was defined as ≥50% stenosis in at least one of the epicardial coronary arteries. Cardiomyopathy was defined as left ventricular ejection fraction of ≤50% Chronic obstructive pulmonary disease was defined as forced expiratory volume in 1st second to forced vital capacity ratio of <70% of the predicted value. Patients were labeled hyperthyroid if they have low serum TSH and high serum concentration of free T4 or T3 as per laboratory reference range.
All patients were followed from the time of inclusion to the time of discharge or till inpatient death. Hemodynamic parameters including heart rate and blood pressure were recorded at the time of inclusion for patients with known atrial fibrillation and at the time of onset of arrhythmia for those with new onset atrial fibrillation. Patients' treatment record were reviewed for medications. Complications related to atrial fibrillation or its treatment were recorded.
- Conditions
- Atrial Fibrillation
- Being tested
- No intervention, as this was retrospective study.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, as this was retrospective study.Other
No intervention performed. Participants were entolled retrospectively and medical records were accessed for data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical charcateristics and management features of atrial fibrillation
To evaluate baseline characteristics of patients admitted with atrial fibrillation.
Measured: July 2018 to December 2018
Secondary outcomes (1)
Clinical charcateristics of atrial fibrillation patients
To identify and compare clinical characteristics of patients with atrial fibrillation.
Measured: July 2018 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirbhat Shams, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082558
- Sponsor's protocol ID
- 2019-1008-2905
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Prognostic Factors of Atrial Fibrillation at a Tertiary Center of Pakistan - From a South-Asian Lens - a Retrospective Study.
- ClinicalTrials.gov ID
- NCT05082558
- Acronym / sponsor ID
- 2019-1008-2905
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Oct 2021 (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.
To evaluate the clinical characteristics and management purseued for atrial fibrillation in a tertiary care center of Pakistan. We aimed at looking baseline characteristics and associated co-morbid conditions and primary diagnosis associated with atrial fibrillation.
Detailed description
It is a retrospective observational study done at Aga Khan University Hospital, Karachi, Pakistan, which is a tertiary care teaching hospital with a cardiology and cardiac surgery center. Aga Khan Hospital is one of the main referral health centers in Pakistan.
This study was approved by Aga Khan University ethical review committee (ERC No. # 2019-1008-2905).We reviewed hospital record files of 651 patients including both males and females, admitted in Aga Khan University Hospital from 1st July 2018 to 31st December 2018, who were found to have atrial fibrillation as a primary or associated diagnosis. Diagnosis of atrial fibrillation was confirmed on a 12 lead ECG. Fifteen patients were excluded who did not have electrocardiographic evidence of atrial fibrillation.
For all patient, demographic information including age and gender, reason of admission and duration of arrhythmia were noted from the written medical records. Comorbidities were tabulated including: diabetes mellitus, hypertension, coronary artery disease, heart failure, cardiomyopathy, valvular heart disease, chronic obstructive pulmonary disease, and hyperthyroidism. Echocardiographic data were reviewed for left atrial (LA) dimension, LA volume index and left ventricular (LV) systolic function.
Patients were labeled as Diabetic if they had HbA1c of >6.5gm/dl or they were already on treatment for diabetes mellitus. Hypertension was defined as average of two readings of systolic blood pressure of ≥140mmHg or diastolic blood pressure of ≥90mmHg or patients already taking antihypertensive medications. Coronary artery disease was defined as ≥50% stenosis in at least one of the epicardial coronary arteries. Cardiomyopathy was defined as left ventricular ejection fraction of ≤50% Chronic obstructive pulmonary disease was defined as forced expiratory volume in 1st second to forced vital capacity ratio of <70% of the predicted value. Patients were labeled hyperthyroid if they have low serum TSH and high serum concentration of free T4 or T3 as per laboratory reference range.
All patients were followed from the time of inclusion to the time of discharge or till inpatient death. Hemodynamic parameters including heart rate and blood pressure were recorded at the time of inclusion for patients with known atrial fibrillation and at the time of onset of arrhythmia for those with new onset atrial fibrillation. Patients' treatment record were reviewed for medications. Complications related to atrial fibrillation or its treatment were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We reviewed hospital record files of 651 patients including both males and females, admitted in Aga Khan University Hospital from 1st July 2018 to 31st December 2018, who were found to have atrial fibrillation as a primary or associated diagnosis. Diagnosis of atrial fibrillation was confirmed on a 12 lead ECG.
Key inclusion criteria (4 listed)
- inpatients
- Age >/= 18 years
- Having atrial fibrillation on 12 lead surface EKG.
- Both males and females.
Key exclusion criteria (2 listed)
- Age <18 years.
- Non-availability of 12 lead EKG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, as this was retrospective study.No intervention performed. Participants were entolled retrospectively and medical records were accessed for data. | Other | – |
Primary outcome
Clinical charcateristics and management features of atrial fibrillation
Time frame: July 2018 to December 2018
To evaluate baseline characteristics of patients admitted with atrial fibrillation.
1 secondary outcome
Clinical charcateristics of atrial fibrillation patients
Time frame: July 2018 to December 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical charcateristics and management features of atrial fibrillation (time frame: July 2018 to December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2021.