Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial Comparing Home-based Training With Telemonitoring Guidance Versus Center-based Cardiac Rehabilitation in Patients With Coronary Heart Disease: the TRiCH-study
Brief Summary: Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage in enough physical activity to obtain benefits or in the long-term struggle to maintain a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on health related physical fitness. One strategy might be the use of home-based training in combination of telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical fitness. It is hypothesized that patients randomized to a home-based training program with telemonitoring guidance will demonstrate higher levels of physical activity at one year of follow-up, resulting in higher levels of physical fitness, compared to patients who have been enrolled to the supervised center-based cardiac rehabilitation program or control group. Ninety patients will be randomized to Home-based training, a center-based cardiac rehabilitation program or an advice only group (= control group). Assessment will be performed at baseline, immediately at completion of the intervention and at one-year of follow-up and will include measurements of exercise tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial function, health-related quality.


Options:
A: Inclusion Criteria:

* patients of either sex with any aetiology of left ventricular systolic HF \[as defined in the European Society of Cardiology (ESC) guidelines\]
* with a left ventricular ejection fraction (LVEF) ≤40% on echocardiography;
* in New York Heart Association (NYHA) class I, II or III;
* who are to have had a hospitalization incident, be stable clinically (a patient does not need intravenous medication or has not had therapy modified for at least 7 days);
* who has no contraindications to undergo cardiopulmonary exercise test and
* who are able to exercise using the new model of home-based telerehabilitation.

Exclusion Criteria:

* NYHA class IV;
* unstable angina;
* unstable clinical status
* a history of acute coronary syndrome within the last forty days in patients with LVEF ≤35%; percutaneous angioplasty (PCI) within the last 2 weeks, coronary artery bypass grafting within the last 3 months, or initiation of cardiac resynchronization therapy (CRT-P, CRT-D) and/or implantable cardioverter-defibrillator (ICD) or pacemaker within the last six weeks;
* lack of ICD, CRT-P or CRT-D therapy despite the indications for implantation according to ESC guidelines;
* intracardiac thrombus
* rest heart rate (HR) \>90/min,
* tachypnoea \>20 breaths per minute
* symptomatic and/or exercise-induced cardiac arrhythmia or conduction disturbances;
* acute myocarditis and/or pericarditis
* valvular or congenital heart disease requiring surgical treatment;
* hypertrophic cardiomyopathy;
* severe pulmonary disease;
* uncontrolled hypertension;
* anemia (haemoglobin \<11.0 g/dL);
* physical disability related to severe musculoskeletal or neurological problems;
* recent embolism;
* thrombophlebitis;
* acute or chronic inflammatory disease;
* acute or chronic decompensated non-cardiac diseases (thyreotoxicosis, uncontrolled diabetes)
* active malignant neoplastic diseases with survival prognosis below 2 - 5 years;
* orthotropic heart transplant in anamnesis;
* aortic aneurysm;
* severe psychiatric disorder; and
* patient's refusal to participate.
B: Inclusion Criteria:

* Patients with CAD (post-PCI, post-MI, post-CABG)
* Patients on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 6 weeks
* Patients have successfully completed the 3 month ambulatory cardiac rehabilitation in hospital program
* 39 yrs \< age \< 76 years
* access to internet facilities or PC at home

Exclusion Criteria:

* Significant undercurrent illness last 6 weeks
* Known severe ventricular arrhythmia with functional or prognostic significance; significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at screening or heart disease that limits exercise
* Co-morbidity that may significantly influence one-year prognosis
* Functional of mental disability that may limit exercise
C: Inclusion Criteria:

* coronary artery disease
* age over 18
* referred to cardiac rehabilitation
* exercise tolerance demonstrated

Exclusion Criteria:

* severe arrhythmia
* heart failure
* drug abuse
* pregnancy
D: Inclusion Criteria:

* All heart failure patients that may benefit from telehealthcare.
* Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4.
* Patients must have a permanent residence and be motivated for using telehealthcare. \*Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.

Exclusion Criteria:

* Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
* Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.
* Comorbidity is not an exclusion criterion.

Answer: B