Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial for Investigating a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease: CardioCare MV
Brief Summary: Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.


Options:
A: Inclusion Criteria:

* 18 years or older
* Documented non valvular atrial fibrillation
* Able to provide informed consent
* Able and willing to complete the study questionnaires on own or with assistance

Exclusion Criteria:

* Referral is for atrioventricular node ablation or pulmonary vein isolation.
* Patients who have failed antiarrhythmic medications
* Patients with moderate to severe mitral or aortic valvular heart disease
* Clinically unstable atrial fibrillation
* Cannot or unwilling to attend follow-up appointments
B: Abbreviations: FBS = fasting blood sugar, SBP = systolic blood pressure, DBP = diastolic blood pressure, LDL = low-density lipoprotein, HDL = high-density lipoprotein, BMI = body mass index, TC = total cholesterol, TG = triglycerides, HbA1c = hemoglobin A1c.

Inclusion Criteria

* The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2) and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker.
* The patient does not have CAD or CAD risk equivalent but has at least one of the following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker.
* The patient does not have CAD or CAD risk equivalent but has at least two of the following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c) LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or female age ≥ 55 or with positive family history of CAD.

Exclusion Criteria:

* Resident of long-term facility
* Lack of spoken English or Spanish by patient or household member 18 years or older who can serve as an interpreter
* Moving before end of intervention (30 months)
* Age between 35 and 85 (inclusive)
* Significant comorbidities such as: uncontrolled metabolic disorders (renal failure, liver failure, etc.), active symptoms suggesting acute myocardial infarction or decompensated congestive heart failure, Malignancy or other condition limiting life expectancy, psychiatric disorder with active manifestations.
* Substance abuse.
* No telephone or means of contacting patient.
* Family household member already enrolled.
* Homeless and not living with relatives/friends.
* Anticipated absence for more than 4 consecutive months.
* Difficulty coming to appointments approximately every 1-2 months
* Already participating in the Diabetes program
* Currently pregnant or intends to get pregnant the next 3 years.
C: Inclusion Criteria:

1. Heart failure (I50, NYHA II-IV) or atrial fibrillation (I48, EHRA II-IV) or resistant hypertension (I10-15, ≥ 3 antihypertensive medicines from different drug classes, SBP \> 140 /90mmHg or ≥ 4 antihypertensives irrespective of the blood pressure, with at least one drug being a diuretic).
2. Member of health insurance company AOK Nordost or Techniker Krankenkasse (TK).
3. Inscription to integrated care contract with the health insurance company.
4. Residence in Mecklenburg-Vorpommern.
5. Age ≥ 18 years.
6. Written informed consent.

Exclusion Criteria:

1. Pregnancy, suspected pregnancy or breast-feeding period.
2. Participation in another clinical trial up to 30 days before inclusion in this trial.
3. Cognitive deficits: patients need to be able to read and understand German language as presented on a tablet.
4. Chronic kidney disease requiring dialysis or creatinine clearance \< 15 ml/min.
D: Inclusion Criteria:

* 1. Patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ECG showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-CABG))
* 2. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors

Exclusion Criteria:

* Mechanical prosthetic valve
* Clinically unstable at the time of enrollment (ie, with ongoing shock)
* Terminal illness and/or comfort care
* Unable to provide consent (e.g. severe cognitive impairment)
* Patients unable to have one year of follow-up for any reason
* Clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ICH)

Answer: C