IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Difference in Left Ventricular End-Systolic Volume (ml)
研究概览
简要总结
The proposed research aims to compare Left ventricular remodeling outcomes among patients with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI treatment vs. non-telemedicine guided treatment.
详细描述
Acute Myocardial Infarction (AMI) accounts for more than 6,000 admissions to Singapore hospitals each year. Contemporary treatment, including percutaneous intervention (angioplasty and stenting) and adjunctive drug therapy, has reduced early mortality from AMI.
In many healthcare systems, Hospital scorecards stipulate prescription of appropriate drugs upon discharge after hospitalization for AMI. These drugs include aspirin, a platelet P2Y12 inhibitor, angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers and lipid-lowering drugs. Such quality improvement programs have led to an increase in prescription of these drugs upon discharge. Yet, 2 problems remain pervasive:
- dose optimization; how the investigators escalate patients to the most effective drug doses, and
- drug adherence; whether patients are taking these drugs regularly.
These 2 problems stem largely from the traditional model of episodic care entailing face-to-face visits between patient and healthcare practitioner. Inadequate dose optimization is most relevant to ACE-I/ARB and beta-blockers as healthcare practitioners necessarily prescribe low doses of these drugs at discharge to avoid excessive lowering of blood pressure soon after an AMI. Yet, these drugs are most effective at preventing adverse ventricular remodeling when patients take them at their maximum tolerated doses. In clinical trials, titrating these ACE-I/ARB and beta-blockers to target doses has required weekly outpatient visits, a model of care that most healthcare systems cannot afford.
The investigators hypothesize that a telemedicine-based system of care will lead to a greater reduction in ventricular remodeling as compared with usual care, by improving dose optimization and adherence to ACE-I/ARB and beta-blockers in patients with recent AMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed STEMI or NSTEMI* within the last 7 days at high risk of ventricular remodeling
- •Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)
- •Typical rise or fall of cardiac enzymes with at least one value of cardiac troponin I≥10 ug/L.
- •ECG changes required for diagnosis of STEMI: ≥0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or presence of Q waves ≥0.02 sec in two or more contiguous limb leads or precordial leads, or new onset left bundle branch block (LBBB), *The definition of STEMI and NSTEMI follows the 3rd universal definition of MI [19]
- •Pre-discharge NTproBNP ≥300 pg/mL for both STEMI and NSTEMI
- •Undergone PCI for the index event
- •Age >21 years and <85 years
排除标准
- •Hypersensitivity to ticagrelor, aspirin or any excipients
- •Active pathological bleeding
- •History of intracranial haemorrhage
- •Bacterial Infection within 6 weeks preceding the primary angioplasty, HIV, autoimmune disease (e.g. SLE, rheumatoid arthritis, scleroderma and Grave's disease, etc) or on immunosuppressive therapy
- •Women of child-bearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period
- •Malignancy within last 2 years
- •History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)
- •Planned CABG within the next 6 weeks
- •Unable to be weaned off inotropes or IABP
- •Active asthma or any other contraindications to beta-blockers
- •Arrhythmias precluding proper CMR image acquisition, such as atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic QRS complexes
- •Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants
- •Severe liver impairment due to chronic liver disease e.g. advanced alcoholic liver cirrhosis or primary biliary cirrhosis
- •Significant renal impairment (eGFR <50ml min-1), end stage renal failure on renal replacement therapy
- •Anaemia (Hb<10 g/dL).
- •Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)
- •Participants who cannot be followed up
- •Participants not able or willing to consent for study.
研究组 & 干预措施
Telemedicine
The telehealth group will be remotely monitored and managed on medication adherence, dosage titration, and management of drug side effects, through a combination of feed-forward blood pressure monitoring, app-based education and medication reminders, and remote consultations.
干预措施: Telemedicine (Other)
Standard care
The standard care group will receive face-to-face consultations at one month, 6 months and 12 months.
结局指标
主要结局
Difference in Left Ventricular End-Systolic Volume (ml)
时间窗: 6 months
Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging
次要结局
- Adenosine diphosphate-induced platelet reactivity(6 months)
- Haemodynamic Stress(6 months)
- Hospitalisation & readmission(2 years)
- Infarct size (grams and % of total LV mass)(6 months)
研究者
Mark Chan
A/Prof Mark Chan
National University Heart Centre, Singapore