STREAM Trial - Subclinical Atherosclerosis

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 28, 2022

Keywords

ClinConnect Summary

The STREAM Trial is studying whether older adults aged 70 and above, who are taking statins to prevent heart disease and have multiple health conditions, may benefit from continuing their statin medication based on the level of coronary artery calcium (CAC) in their bodies. CAC is a measure of early heart disease that can help doctors assess risk. The trial aims to see if stopping statins leads to more heart-related problems or even death in these patients compared to those who keep taking their statins.

To participate in this trial, individuals must be at least 70 years old, have two or more chronic health conditions, and have been on statins regularly for the past year. Those with a history of serious heart issues or certain other health complications are not eligible. Participants will be divided into two groups: one will continue taking their statins, while the other will stop. Researchers will closely monitor their health over time to determine the effects of stopping the medication. This trial is important because it could help identify which older adults truly need to continue statin therapy to reduce their risk of heart problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥70 years of age
• • Multimorbid with ≥2 coexistent chronic conditions (defined by ICD-10 codes) with an estimated duration of 6 months or more based on clinical decision, besides dyslipidemia treated by statins
• • Taking a statin for ≥80% of the time during the year before baseline
• Exclusion criteria:
• 1. Secondary prevention based on previous large statin trials, defined as:
• • History of myocardial infarction type 12 (NSTEMI/STEMI) OR
• • History of unstable angina, defined as ACS symptomatic at rest, crescendo or new-onset angina (CCS 2 or 3) without ECG or cardiac biomarker changes (based on available documents) OR
• • Stable angina pectoris with a documented ischemia on a stress test or with a significant coronary disease defined as a coronary stenosis \>50% OR
• • History of percutaneous coronary intervention (balloon or stent) or coronary artery bypass graft OR
• • History of ischemic stroke OR
• • History of Transient Ischemic Attack, defined as transient neurological deficit without diffusion restriction in MRI OR
• • History of carotid revascularization (stent or bypass) OR
• • History of peripheral arterial disease requiring revascularization (stent or bypass; Fontaine IV)
• • 2. Aortic disease that required a vascular repair or aortic aneurysm with a maximum diameter \>5.5 cm (men) or \>5.2 cm (women) based on available documents
• • 3. Diagnosis of familial hypercholesterolemia based on Dutch lipid score ≥6 based on available documents (LDL-c, Family History, Personal History)
• 4. Elevated risk of death within 3 months after baseline, defined as:
• • Hospitalized patients planned for palliative care within 24h of admission OR
• • Hospitalized patients with a Palliative Performance Scale (PPS) level \<30% (based on situation at least 1 month before hospitalization), this corresponds to an estimated survival of 43% after 3 months; OR
• • Patients with an advanced metastatic cancer prognosis of ≤20% survival rate within 1 year after baseline (based on an online tool: https://cancersurvivalrates.com)
• • 5. Body measures exceeding the CT scanner limits (morbid obesity exceeding weight and diameter limits)
• • 6. Cardiac implants with metallic interference, such as pacemaker and mechanical heart valves
• • 7. Orthopedic hardware in the mid or lower thoracic spine
• • 8. Inability to hold breath for 10 seconds