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Study design and baseline characteristics of the study to evaluate carotid ultrasound changes in patients treated
1Division of Cardiology and Preventive Cardiology, Hamilton Civic Hospitals Research Center, McMaster University, Ontario, Canada.
Insights
This study investigated if ramipril and vitamin E slow atherosclerosis progression in high-risk patients. Results are pending, but the trial aims to reveal mechanisms behind potential cardiovascular event reduction.
Area of Science:
- Cardiology
- Vascular Biology
- Pharmacology
Background:
- Atherosclerotic cardiovascular disease is a leading cause of death globally.
- Angiotensin-converting enzyme inhibitors and vitamin E show potential in retarding atherosclerosis, but human data are limited.
- High-risk patients require effective strategies to slow disease progression.
Purpose of the Study:
- To assess the effects of ramipril (2.5 mg and 10 mg daily) and vitamin E (400 IU daily) on atherosclerosis progression.
- To investigate the mechanisms underlying the potential benefits of these treatments on cardiovascular health.
- To evaluate these effects in high-risk patients using carotid ultrasonography.
Main Methods:
- The Study to Evaluate Carotid Ultrasound Changes in Patients Treated with Ramipril and Vitamin E (SECURE) enrolled 732 high-risk patients.
- A factorial 3x2 study design was employed, assessing two doses of ramipril and vitamin E.
- Atherosclerosis progression was measured noninvasively using B-mode carotid ultrasonography over 4 years.
Main Results:
- The SECURE trial is ongoing; definitive results on atherosclerosis progression are not yet available.
- This substudy complements the larger Heart Outcomes Prevention Evaluation (HOPE) study, which examines major cardiovascular events.
- Data will elucidate how ramipril and vitamin E may impact subclinical atherosclerosis.
Conclusions:
- The SECURE trial will provide crucial insights into the mechanistic effects of ramipril and vitamin E on atherosclerosis.
- Understanding these mechanisms can inform future therapeutic strategies for cardiovascular disease prevention.
- The findings will contribute to a comprehensive understanding of cardiovascular risk reduction.
Abstract:
Atherosclerotic cardiovascular disease remains a major cause of mortality and morbidity in most developed countries. Experimental and clinical evidence suggests that angiotensin-converting enzyme inhibitors and vitamin E therapy may retard the atherosclerotic process; however, definitive proof in humans is lacking. The Study to Evaluate Carotid Ultrasound Changes in Patients Treated with Ramipril and Vitamin E (SECURE) is designed to assess the effects of ramipril--an angiotensin-converting enzyme inhibitor, at 2 doses: 2.5 mg daily (which has little effect on lowering blood pressure) and 10 mg daily--and the antioxidant vitamin E, 400 IU daily, on atherosclerosis progression in 732 patients using a factorial 3 x 2 study design. High-risk patients with a documented history of significant cardiovascular disease or with diabetes and additional risk factors were enrolled and will be followed for 4 years. The extent and progression of atherosclerosis are assessed noninvasively by B-mode carotid ultrasonography. The SECURE trial is a substudy of the larger Heart Outcomes Prevention Evaluation (HOPE) study of 9,541 high-risk patients evaluating the effects of ramipril and vitamin E on major cardiovascular events (cardiovascular death, myocardial infarction, and stroke). The 2 studies are complementary. Whereas HOPE is expected to provide information on major clinical outcomes, SECURE will shed light on the mechanisms by which these effects may be mediated.