Atrial Fibrillation Clinical Trial
Official title:
Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF
NCT number | NCT05014802 |
Other study ID # | 2021-622 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 21, 2021 |
Est. completion date | June 2024 |
The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 120 Years |
Eligibility | Inclusion Criteria: - Male or female patients age 40 years of age or older - Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair/reconstruction, aneurysm repair, and insertion of pacemaker). Exclusion Criteria: - Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) - Patients with a history of cardiac or open chest surgery - Patients with a history of catheter ablation - Patients under the age of 40 - Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted - Patients who have previously undergone extracorporeal membrane oxygenation (ECMO) - Patients who have undergone or will undergo heart transplantation - Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices/implants contraindicated for MRI) - Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), <30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition). - Patients weighing > 300 lbs. (MRI image quality decreases due to increased body mass index) - Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period - Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study - Patients who cannot read, speak, and/or understand English |
Country | Name | City | State |
---|---|---|---|
United States | Tulane University Medical Center | New Orleans | Louisiana |
United States | University Medical Center New Orleans | New Orleans | Louisiana |
United States | Washington University Barnes-Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Tulane University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of atrial arrhythmia in patients after cardiac surgery | The incidence of any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia etc.) from after their surgical procedure to their discharge from the hospital.
Atrial arrhythmia is defined as any abnormal atrial rhythm episode continuing for more than 30 seconds, starting immediately after the patient arrives at the post-operation ICU. All atrial arrhythmia starting after the operation will be monitored and recorded. This will be measured using continuous telemetry and/or serial ECG monitoring. |
2 weeks | |
Secondary | Rate of in-hospital mortality | In-hospital mortality is defined as patient death during any point of hospital stay following cardiac surgery. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Hospital and Intensive Care Unit (ICU) length of stay (LOS) | LOS is defined as duration from admission to discharge in days in the hospital and ICU. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of stroke | Stroke is defined as sudden loss of brain function caused by an interruption of blood supply to the brain either through an ischemic or hemorrhagic modality. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of acute respiratory failure | Acute respiratory failure is any decrease in respiratory function resulting in hypoxemia (low arterial oxygen levels), hypercapnia (elevated levels of carbon dioxide gas) or a combination of the two. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of sudden cardiac arrest | Sudden cardiac arrest is the abrupt loss of heart function, breathing and consciousness. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of shock | Shock is a critical condition brought on by the sudden drop in blood flow through the body. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of systemic or pulmonary embolism | An embolus is a blood clot that forms in the systemic or pulmonary circulation that jeopardizes normal blood flow to the area causing organ dysfunction. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Incidence of infection post surgery | Infection is the invasion and multiplication of microorganisms in any area of the body, specifically the heart, lungs, blood and gastrointestinal and urinary tract. This will be measured through patients medical chart review. | 2 weeks | |
Secondary | Hospitalization costs to the patient | All costs related to the current episode of hospitalization including procedures, medication, personnel and machine time, calculated prior to insurance or Medicaid/Medicare discount. This will be obtained through hospital billing department. | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |