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| [ Print-friendly version ] |
| ANGIO-EX study: to determine whether the blood circulating protein angiopoietin like-2 (angptl2) is associated with a poor vessel health in young and old healthy volunteers, patients with a coronary artery heart disease and in obese subjects |
| ISRCTN | ISRCTN46169845 |
| DOI | 10.1186/ISRCTN46169845 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | ANGIO-EX study: to determine whether the blood circulating protein angiopoietin like-2 (angptl2) is associated with a poor vessel health in young and old healthy volunteers, patients with a coronary artery heart disease and in obese subjects |
| Scientific title | A randomized trial to determine whether circulating levels of angptl2 correlates with the improvement in cardiopulmonary fitness associated with a exercise training-based secondary prevention in coronary artery disease patients and obese subjects compared to age-matched healthy, physically active volunteers |
| Acronym | ANGIO-EX |
| Serial number at source | ANGIO-EX 11-1328 |
| Study hypothesis | The clinical benefits of exercise is associated with a reduction in circulating levels of angptl2 and a modification of the leukocyte epigenome signature towards that of age-matched healthy physically active subjects |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Montreal Heart Institute, Comité d’Éthique de la Recherche et du Développement des Nouvelles Technologies, 24 November 2011, ref: 11-1328 |
| Study design | Four year open randomised parallel groups single-site trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Aging and age-related cardiovascular diseases |
| Participants - inclusion criteria |
In phase 1, two groups (n=20 each) of healthy and physically trained volunteer members (men and women) of aged 18 to 39 years and 50 to 70 years.
Obese subjects (n=20) aged 50 to 70 years, men and women. Healthy subjects are defined as men and women without cardiac, pulmonary or muscular diseases. Obese patients are recruited at a BMI >30 kg/m2, without cardiac, pulmonary and muscular disease. In phase 2 of the study, newly referred patients with CHD (n=20) aged 50 to 70 years, and obese subjects (n=20) aged 50 to 70 years, men and women. Inclusion criteria for CHD patients are: 1. Documented prior acute coronary syndrome 2. Documented coronary revascularization or documented myocardial ischemia or necrosis on myocardial scintigraphy. Obese patients are recruited at a BMI >30 kg/m2, without cardiac, pulmonary and muscular disease. |
| Participants - exclusion criteria |
Active smokers (≥1 cigarette per day) are excluded.
Exclusion criteria for healthy subjects: 1. Dyslipidemia (total cholesterol > 5.20 mM 2. HDL < 1.04 mM 3. LDL > 2.60 mM 4. Triglycerides > 1.7 mM or use of lipid-lowering therapy) 5. Hypertension (SBP >140 or DBP >90 mmHg or use of antihypertensive medications) 6. Treated or untreated diabetes mellitus 7. Impaired fasting glucose (>5.6 mM) 8. Overweight or obesity (BMI>25 kg/m2) 9. Abdominal obesity (waist circumference >90 cm in men, 80 cm in women) 10. Documented CHD (prior acute coronary syndrome, prior coronary revascularization, presence of myocardial ischemia or necrosis on myocardial scintigraphy), and for any other contraindication to exercise testing/training. Exclusion criteria for CHD patients are: 1. Recent acute coronary event (within one month of inclusion) 2. History of exercise-induced or severe arrhythmias, unstable angina, pacemaker or defibrillator, presence of a pulmonary or skeletal muscle disease limiting maximal exercise testing/training 3. Body mass index (BMI) >28 kg/m2. Exclusion criteria for obese subjects is the presence of a pulmonary or skeletal muscle disease limiting maximal exercise testing/training. |
| Anticipated start date | 15/01/2012 |
| Anticipated end date | 20/12/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
Phase 1 will consist of measuring angptl2 in the blood extracted from two groups of healthy and physically trained volunteers (men and women) and a group of obese subject (men and women). At enrolment, participants provide written informed consent form and undergo a complete medical history and physical examination including measurement of anthropometric variables and body composition with bioelectrical impedance analysis (Tanita BC 418, Japan). A fasting blood profile (total cholesterol, HDL, LDL, triglycerides, free fatty acids, glycaemia, insulin, HbA1c, CRP) will be measured in the clinical biochemistry laboratory of the MHI, while angptl2 is measured by ELISA in the laboratory of Professor Thorin. Blood will be drawn between 8 and 9 a.m.
On a separate, non-fasting day, obese and healthy study participants will perform a maximal cardiopulmonary exercise test on a bicycle ergometer using an incremental protocol with gas exchange analysis. This test represents the gold standard assessment of maximal aerobic exercise capacity (VO2max). One week later, on a separate non-fasting day, volunteers will perform one of the two-planned isocaloric exercises test, a maximal intensity continuous exercise (MICE) or the high intensity interval exercise (HIIE) test. These tests will be performed at one-week interval. Blood will be collected before, and 20 min, 24 and 72 hours after the end of the exercise test in non-fasting condition (2 h after breakfast). MICE is a continuous cycling at 60% of VO2max. Electrocardiogram is continuously recorded and monitored for cardiac arrhythmias, and systolic arterial pressure is determined at 2 min intervals for abnormal blood pressure response during the 28-min test. The HIIE is 35-min long and consists of a standardized 5-min warm-up bout at 50% of mean arterial pressure followed by a set of three 10-second bouts at 100% of VO2max interspersed by 1 min of active recovery at 50% of mean arterial pressure. A 5-min passive recovery phase separated the warm-up from the HIIE session. In phase-2 of this clinical study, we will follow two groups of 20 patients (men and women) either with documented CHD or obesity. All study participants in phase-2 will be newly referred Montreal Heart Institute prevention centre members and “naive” to our prevention programs. Again, at enrolment, participants will provide written informed consent followed by a complete medical history and physical examination as noted above. Fasting blood profile will be measured as above. The VO2max will be acquired on a separate, non-fasting day. Subjects will then be incorporated into the prevention program consisting of individualized nutritional counselling, optimized HIIE and resistance training two to three times a week. CHD patients will follow a 3-month protocol; obese patients will follow a 9-month weight loss protocol. At the end of each program, subjects will undergo the same evaluation as at baseline including medical history and physical examination, fasting blood profile and maximum cardiopulmonary evaluation. All phase 2 patients enrolled will be on optimal medical therapy for a minimum of 4 weeks prior to inclusion. |
| Primary outcome measure(s) | Measure of circulating levels of angptl2 |
| Secondary outcome measure(s) | To demonstrate modifications in biomarkers including leukocyte epigenetic changes after a secondary prevention program |
| Sources of funding | Foundation of the Montreal Heart Institute (Canada) |
| Trial website | |
| Publications | |
| Contact name | Prof Eric Thorin |
| Address |
Montreal Heart Institute
Research Centre 5000, Belanger Street |
| City/town | Montreal |
| Zip/Postcode | H1T 1C8 |
| Country | Canada |
| eric.thorin@umontreal.ca | |
| Sponsor | Montreal Heart Institute (Canada) |
| Address |
c/o Gilles Lefebvre
5000, Belanger Street |
| City/town | Montreal |
| Zip/Postcode | H1T1C8 |
| Country | Canada |
| Date applied | 18/02/2013 |
| Last edited | 27/02/2013 |
| Date ISRCTN assigned | 27/02/2013 |
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