Design of human atherosclerosis studies by serial angiography

Autor: H. P. Chin, Samuel H. Brooks, Robert H. Selzer, Paul K. Hanashiro, Miguel E. Sanmarco, David H. Blankenhorn, Ronald H. Selvester
Rok vydání: 1980
Předmět:
Zdroj: Journal of Chronic Diseases. 33:347-357
ISSN: 0021-9681
DOI: 10.1016/0021-9681(80)90044-2
Popis: Atherosclerosis has been studied by femoral angiography in men with myocardial infarction. Smoking history recorded at entry was the strongest variable asssociated with degree of atherosclerosis at the first angiogram. This correlation was significant at the 1% level in two out of three femoral segments. Fifty-four men had two angiograms; 28 of these men had one additional angiogram. Two variables recorded in the interval between angiograms were significantly correlated with atherosclerosis change in one femoral segment; α-lipoprotein level determined by electrophoresis (a negative correlation, p < 0.01) and maximum systolic blood pressure occurring during an exercise tolerance test (a positive correlation, p < 0.01). An estimate of angiographic atherosclerosis assessment error has been obtained (S.D. = 8.28; in a scale of 1–128) and used to calculate sample size for future clinical trials which employ this endpoint. Testing the effect of therapy on lesion change with angiography requires fewer study subjects observed for a shorter period than is necessary to test a commensurate effect on atherosclerosis-related morbidity or mortality rates. For example, an angiographic study with design features comparable to those of the Coronary Drug Project could require a 1-yr observation period and 132 subjects per test group.
Databáze: OpenAIRE