cardiovascular diseases
Conditions
Interventions
Group 1: The study will be conducted as a case-control observation in individuals who have suffered a myocardial infarction >12 months ago (patient-proband).
The patient-proband will be slowly and gr
Sponsors
DLR- Deutsches Zentrum für Luft- und Raumfahrt - Institut für Luft- und Raumfahrtmedizin
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Consenting healthy volunteers and patients 50 years of age or older Experience at high altitudes if possible Control subjects: o Male or female o Very good physical fitness o No relevant previous diseases of the cardiovascular system Patient subjects: o Condition following myocardial infarction that occurred at least 12 months ago and is adequately treated with medication. With occlusion of a left coronary artery (ramus interventricularis anterior, RIVA or ramus circumflexus, RCX) and restored normal blood flow in the coronary arteries o Successful completion of post-infarct rehabilitation o mildly to moderately impaired left ventricular function (>35%) o Physical exercise capacity within the range of age norm (exercise ECG).
Exclusion criteria
Exclusion criteria: Lack of 2 G status regarding SARS CoV 2 Infarction of the right heart Multivessel disease of the heart Condition after bypass surgery Lack of pharmacological therapy for chronic heart failure Lack of optimal revascularization by a stent (decision based on the based on the last coroanarangiography) Myocardial infarction less than 12 months ago Known relevant pulmonary hypertension Severe lung or kidney disease Severe anemia or iron deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether progressive severe normobaric hypoxia can restore normal ventricular function in a human subject, as previously demonstrated in animal models. This is an exploratory feasibility study. Therefore, primary and secondary end points are all considered exploratory. Nevertheless, defining ventricular wall motion, delayed enhancement with gadolinium, T1 times, and strain (by cardiac MRI and echocardiography) after exposure to hypoxia compared with baseline is a major objective of this study (primary end point). Exploratory end points: - MRI of the brain (changes in tissue volume, edema formation, microhemorrhages, white matter lesions). - systolic blood pressure - diastolic blood pressure - pulse - oxygen saturation (blood gas analysis) - mean pulmonary blood pressure (estimation by echo) - Clinical symptoms - Altitude sickness (Lake Luis score and AMS-C score) - Altitude sickness medications taken by the individual (pain medications, anti-nausea medications, sleeping pills) - 24-hour caloric intake - Structure (MRI, ultrasound) and function of skeletal muscles - polysomnography - actigraphy - Nitrogen metabolism from urine samples (24 h urine collection) - Biomarkers for DNA repair mechanisms - Biomarkers for glucose and fructose metabolism - Biomarkers for microRNA | — |
Secondary
| Measure | Time frame |
|---|---|
| - left ventricular wall motion, strain (by echo after the end of hypoxia compared to baseline) - cMRI measures of fibrosis, after the end of hypoxia compared to baseline - Prove the feasibility and safety of subacute severe hypoxia (oxygen concentration of 8 % over 2 weeks) as a research platform in one healthy female and one healthy male control subject. | — |
Countries
Germany
Contacts
Public ContactJens Tank
DLR - Deutsches Zentrum für Luft- und Raumfahrt - Institut für Luft- und Raumfahrtmedizin
Outcome results
None listed