Multicomponent Risk Factor Modification Intervention focused on healthy eating, regular exercise and behavioural therapy

Atrial Fibrillation

Healthy eating, regular exercise and behavioural therapy.

Multicomponent Risk Factor Modification

Implantable Loop Recorder description from the Mayo Clinic

Kingston Health Sciences Centre

Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation (LIFE-AF)

Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation - A Pilot Study - The LIFE-AF Trial

To assess the impact of a lifestyle intervention on AFIB-related symptom burden as measured by the University of Toronto AFIB Severity Scale (AFSS) scores at 1, 3, 6, and 12 months. This is a validated scale (range, 3.25 [single minimally symptomatic episode lasting minutes] to 30 [continuous highly symptomatic episode lasting >48hours]) which encompasses 3 domains of atrial fibrillation: event frequency (scored 1-10), duration (scored 1.25-10), and global episode severity (scored 1-10).

To assess the impact of a lifestyle intervention on AFIB burden as documented from implantable loop recorders at 1, 3, 6 and 12 months. We will document the change in the number of AFIB episodes. This will be monitored by the ILR recording device where any episode of AFIB over 30 seconds will count as 1 episode. The AFIB events recorded by the device will be adjudicated for accuracy using 2 raters.

To assess the impact of a lifestyle intervention (multicomponent risk factor modification) on quality of life at 1, 3, 6, and 12-months using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire. This assesses treatment concerns and daily activity.

To assess the impact of a lifestyle intervention on a composite end-point at 12 months (combined stroke, myocardial infarction and hospitalization). This information will be collected from hospital records.

Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of monosaccharides in the gut microbiota at baseline and at 12 months.

Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of short-chain fatty acids in the gut microbiota at baseline and at 12 months.

To assess the impact of a lifestyle intervention on weight changes relative to weight measured at baseline.

To evaluate the adherence to the lifestyle intervention (multicomponent risk factor modification) as measured using the International Physical Activity Questionnaire (IPAQ) Short Last 7 Days Self-Administered Format at 1, 3, 6, and 12 months.

To assess the impact of a lifestyle intervention (multicomponent risk factor modification) on 1-, 3-, 6-, and 12-month physical activity levels measured using the Apple Watch step counts per week.

To evaluate the adherence to the lifestyle intervention (multicomponent risk factor modification) as measured using the Multi-Ethnic Study of Atherosclerosis (MESA) Typical Week Physical Activity Survey (TWPAS) at 1, 3, 6, and 12 months.

To evaluate the adherence to the lifestyle intervention (multicomponent risk factor modification) as measured using the Mediterranean Diet Score Tool, a validated 14-item Questionnaire of Mediterranean diet adherence at 1, 3, 6, and 12 months.

To assess the impact of a lifestyle intervention (multicomponent risk factor modification) on 1-, 3-, 6-, and 12-month physical activity levels measured using the Apple Watch duration (minutes) of physical activity per week.

Dr. Benedict Glover

Principal Investigator, Chief of Cardiac Arrhythmia Service, Department of Medicine

Abbott

University of Toronto

A randomization schedule will be prepared by the data coordinating centre at Queen's University, Kingston, Ontario using a computerized random number-generator. Random allocation will be determined by a patient randomization software application. Participants will be randomized on a 1:1 fashion between active intervention and control.

Data downloaded from the participants' implantable loop recorders will not be available to the investigators nor anyone involved in direct patient interaction in the study. A blinded event committee composed of three physicians with a specialization in cardiology, who are not directly involved in the research study, will have access to this data.

Patients received a 8h preoperative fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g) and no infusion of intraoperative w-3-PUFA

Patients received preoperative fast for solids but allowed to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)

Patients received a 8h fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g), and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)

Patients received preoperative fast for solids for 8h but allowed to drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative intravenous w-3-PUFA

Atrial Fibrillation Rapid

Postoperative Complications

Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia

CHO (carbohydrate)

Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA

intravenous w-3 PUFA

Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia, plus an intravenous dose of w3-PUFA intraoperatively

CHO (carbohydrate) plus intravenous w3-PUFA

Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

Preoperative Carbohydrate Load and Intraoperative Omega-3 Polyunsaturated Fatty Acids Positively Impacts in Nosocomial Morbidity After CAGB Surgery. A Double-blind Randomized Trial.

categorical data (patients either had or not had POAF

categorical data (patients either need or not need vasoactive drug

categorical data (patients either had or not had postoperative morbidity

Jose Eduardo de Aguilar-Nascimento

Chair Professor, MD, PhD

Federal University of Mato Grosso

20 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes. Included pioglitazone 15 mg 1 time per day in the morning for 6 months.

23 patients who received standard medical therapy complex: isosorbide dinitrate 10-20 mg 2 times a day, acetylsalicylic acid 75 mg 1 time a day, bisoprolol 2.5 mg 1 time a day, rosuvastatin 20 mg 1 time a day, ramipril 5 mg 1 time a day. Patients also received recommendations on diet and lifestyle changes.

Adverse Effect

Atherosclerosis, Coronary

Insulin Resistance Syndrome

1 tablet per day in the morning for 6 months

Pioglitazone 15 mg Tablet

Isosorbide Dinitrate 10Mg Tablet

Acetylsalicylic Acid 75Mg Tablet

Bisoprolol Fumarate 2.5 MG Oral Tablet

Rosuvastatin Calcium 20 MG Oral Tablet

ramipril 5 MG

Ukrainian Medical Stomatological Academy

Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

Effect of Pioglitazone on Insulin Resistance, Progression of Atherosclerosis and Clinical Course of Coronary Heart Disease

hospitalization due to acute coronary syndrome or unstable angina

Liver injury characterized by ALT>2 upper levels or total bilirubin > 2 upper levels

Incidence of percutaneous coronary intervention

Kidney injury characterized by an increase of creatine in the blood serum of more than 115 umol / l (men) and 97 mmol / l (for women), as well as the increase in the microalbuminuria over 33.9 mg / mol (or 300 mg / l).

Increasing the thickness of the carotic intima-media greater than 0.9 mm.

Hemodynamically significant stenosis - narrowing of the arterial lumen by more than 50%.

Presence of atherosclerotic plaque of the intima media of common carotid artery greater than 1.4 mm.

The increase level of C reactive protein more than 3 mg / L.

Increase in total serum cholesterol levels greater than 5.5 mmol / L

Increase in serum triglycerides over 2.29 mmol / L

Increase in high density lipoproteins level greater than 1.8 mmol / l (men) and more than 2.1 mmol / l (for women), and low density lipoproteins levels greater than 2.8 mmol / L lipoproteins

Impaired glucose tolerance characterized by glucose level at more than 7.8 but less than 11.0 mmol / l. The presence of type 2 diabetes was determined by the level of glucose in the blood over 11.0 mmol / l

atrial fibrillation/carbohydrate

Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation (LIFE-AF)

Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

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