Atrial FibrillationNCT03854448
The Incidence and Predictors of Developing Atrial Fibrillation in Patients With Inferior ST-segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
An observational study of Atrial Fibrillation, run by Assiut University.
Trial summary
Is to analyze the incidence and predictors of developing AF in patients with inferior infarction who undergo PCI with and without atrial and SN branches occlusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- holter monitoring
- Type of treatment
- Medical device
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Sep 2019
- 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
- Adult, Older adult
Study population: patients with inferior S-T elevation myocardial infarction
Who may be able to join
- Patients with inferior STEMI who will undergo PPCI (primary percutaneous coronary intervention )
Who cannot join
- -A history of preexisting AF
- Prior documentation of heart failure or reduced left ventricular ejection fraction < 50%,
- Severe valvular disease ( rheumatic , sclerotic ) or secondary to AMI
- Left ventricular hypertrophy : enlargement and thickening of the walls of the ventricle
- Patients with inferior STEMI treated with intravenous thrombolysis or conservative strategy
- Patients with inferior STEMI who undergo primary PCI and associated with right ventricular or posterior infarction
- History of pulmonary embolism or COPD ( chronic obstructive pulmonary disease )
- Those with thyrotoxicosis
Trial locations and contacts
No sites are listed yet.
About this study
Is to analyze the incidence and predictors of developing AF in patients with inferior infarction who undergo PCI with and without atrial and SN branches occlusion
Read the detailed description
Atrial fibrillation (AF) occurs in 5% to 18% of patient with acute ST-segment elevation myocardial infarctions (STEMIs) and 4.5% in patients with STEMI treated with percutaneous coronary intervention (PCI).
Diagnosis of AF in acute myocardial infarction (AMI) patients is important because it increases the risk of cardiovascular event and associated with increased in-hospital and long term rates . Atrial ischemia/infarction translates into P Q segment depression or elevation on the electrocardiogram and often associates with atrial tachyarrhythmias .
Side-branch obstruction is one of the adverse effects of PCI the location of the culprit vessel also affects the occurrence of AF in AMI Atrial arteries arise from the right coronary artery (RCA) and circumflex coronary artery (CX) and extend through the atrial myocardium to supply both chambers It is therefore conceivable that PCI of lesions located at the RCA and CX could lead to an accidental atrial branch occlusion .
Atrial myocardial ischemia secondary to atrial branches occlusion (ABO) might lead to mechanical atrial dysfunction, increased electrical vulnerability to atrial arrhythmias, and late structural remodeling .
The sino nodal (SN) artery originates from the proximal portion of the RCA in about 60% of humans Side branch occlusion of the SN artery occurring accidentally during PCI for proximal RCA lesions would provide an opportunity to produces SN dysfunction in humans. Uptill now , there have been no systematic studies concerning SN dysfunction caused by side-branch occlusion of the SN artery during PCI .
Left atrial volume seems to be a strong predictor of incident of AF , with increase in left atrial filling pressures, atrial stretch and enlargement of the chamber occur, leading to remodeling of the structure, physiologic properties, and electrical milieu of the left atrium, culminating in the development of AF
- Conditions
- Atrial Fibrillation
- Being tested
- holter monitoring
- Keywords
- inferior STEMI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holter monitoringDevice
Also called echocardiography
Transthoracic Echocardiography (TTE) Left atrial ( LA) volume will be measured using standard apical two- and four-chamber views on the frame just prior to mitral valve opening and as specified by current American Society of Echocardiography guidelines (10) LA volume is indexed to body surface area. Mitral inflow velocity is obtained in the apical four-chamber view by placing a pulsed-Doppler sample volume between the tips of the mitral leaflets. Mitral annular velocity is assessed during the early phase of diastole(e=) using pulsed-wave Doppler sampling of septal mitral annular motion from the four chamber view.
24 to 48 hours Holter monitoring after 1 month after PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention
incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention
Measured: baseline
Secondary outcomes (1)
atrial branches occlusion and left atrial volume index as predictors of atrial fibrillation
atrial branches occlusion and left atrial volume index as predictors of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study startMar 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
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.
- 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
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed atef ahmed atef, Assiut University
- Investigators
- Yehia Taha Kishk kishk, MD, Study chair, Professor of cardiology department Assiut UniversityMohamed Ali Mohamed Tohamy tohamy, MD, Study director, Lecturer of cardiology department Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854448
- Sponsor's protocol ID
- AF in inferior STEMI after PCI
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 28 Feb 2019
- 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 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Predictors of Developing Atrial Fibrillation in Patients With Inferior ST-segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03854448
- Acronym / sponsor ID
- AF in inferior STEMI after PCI
- Conditions
- Atrial Fibrillation
- Keywords
- inferior STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
Is to analyze the incidence and predictors of developing AF in patients with inferior infarction who undergo PCI with and without atrial and SN branches occlusion
Detailed description
Atrial fibrillation (AF) occurs in 5% to 18% of patient with acute ST-segment elevation myocardial infarctions (STEMIs) and 4.5% in patients with STEMI treated with percutaneous coronary intervention (PCI).
Diagnosis of AF in acute myocardial infarction (AMI) patients is important because it increases the risk of cardiovascular event and associated with increased in-hospital and long term rates . Atrial ischemia/infarction translates into P Q segment depression or elevation on the electrocardiogram and often associates with atrial tachyarrhythmias .
Side-branch obstruction is one of the adverse effects of PCI the location of the culprit vessel also affects the occurrence of AF in AMI Atrial arteries arise from the right coronary artery (RCA) and circumflex coronary artery (CX) and extend through the atrial myocardium to supply both chambers It is therefore conceivable that PCI of lesions located at the RCA and CX could lead to an accidental atrial branch occlusion .
Atrial myocardial ischemia secondary to atrial branches occlusion (ABO) might lead to mechanical atrial dysfunction, increased electrical vulnerability to atrial arrhythmias, and late structural remodeling .
The sino nodal (SN) artery originates from the proximal portion of the RCA in about 60% of humans Side branch occlusion of the SN artery occurring accidentally during PCI for proximal RCA lesions would provide an opportunity to produces SN dysfunction in humans. Uptill now , there have been no systematic studies concerning SN dysfunction caused by side-branch occlusion of the SN artery during PCI .
Left atrial volume seems to be a strong predictor of incident of AF , with increase in left atrial filling pressures, atrial stretch and enlargement of the chamber occur, leading to remodeling of the structure, physiologic properties, and electrical milieu of the left atrium, culminating in the development of AF
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with inferior S-T elevation myocardial infarction
Key inclusion criteria (1 listed)
- Patients with inferior STEMI who will undergo PPCI (primary percutaneous coronary intervention )
Key exclusion criteria (8 listed)
- -A history of preexisting AF
- Prior documentation of heart failure or reduced left ventricular ejection fraction < 50%,
- Severe valvular disease ( rheumatic , sclerotic ) or secondary to AMI
- Left ventricular hypertrophy : enlargement and thickening of the walls of the ventricle
- Patients with inferior STEMI treated with intravenous thrombolysis or conservative strategy
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 |
|---|---|---|
| holter monitoringAlso: echocardiographyTransthoracic Echocardiography (TTE) Left atrial ( LA) volume will be measured using standard apical two- and four-chamber views on the frame just prior to mitral valve opening and as specified by current American Society of Echocardiography guidelines (10) LA volume is indexed to body surface area. Mitral inflow velocity is obtained in the apical four-chamber view by placing a pulsed-Doppler sample volume between the tips of the mitral leaflets. Mitral annular velocity is assessed during the early phase of diastole(e=) using pulsed-wave Doppler sampling of septal mitral annular motion from the four chamber view. 24 to 48 hours Holter monitoring after 1 month after PCI | Device | – |
Primary outcome
incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention
Time frame: baseline
incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention
1 secondary outcome
atrial branches occlusion and left atrial volume index as predictors of atrial fibrillation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Clinical factors associated with the development of atrial fibrillation in the year following STEMI treated by primary PCILink provided by the sponsor.
- Impact of atrial fibrillation in patients with ST-elevation myocardial infarction treated with percutaneous coronary interventionLink provided by the sponsor.
- Acute regional left atrial ischemia causes acceleration of atrial drivers during atrial fibrillationLink provided by the sponsor.
- Atrial coronary artery occlusion during elective percutaneous coronary angioplastyLink provided by the sponsor.
- Sinus arrest caused by occlusion of the sinus node artery during percutaneous coronary intervention for lesions of the proximal right coronary arteryLink provided by the sponsor.
- Left Atrial Volume: Important Risk Marker of Incident Atrial FibrillationLink provided by the sponsor.
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Atrial Fibrillation (AF)
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.
Yehia Taha Kishk kishk, MD study chair
Professor of cardiology department Assiut University
Mohamed Ali Mohamed Tohamy tohamy, MD study director
Lecturer of cardiology department Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, 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 8 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 28 Feb 2019. 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 ahmed atef ahmed atef atef (01156930941, ahmed3242166@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention (time frame: baseline). 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 28 Feb 2019.