Efficacy and safety of a novel pharmacological stress test agent-higenamine in radionuclide myocardial perfusion imaging: phase Ⅱ clinical trial / 中华核医学与分子影像杂志

ABSTRACT

Objective To evaluate the effectiveness and safety of higenamine (HG),a pharmaco logical stress agent,for the detection of myocardial ischemia using SPECT.Methods This study was an open,multi-center,randomized and positively controlled trial with crossover references.It consisted of 120patients clinically confirmed or suspected of myocardial ischemia.Each patient underwent a resting MPI and two separate stress MPI in a randomized crossover manner with intravenous administration of HG or adenosine (Ad) on different days.The severity and extent of myocardial ischemia were diagnosed on stress MPI.The degree of vascular stenosis in terms of percentage narrowing was measured by CAG (＞50％ was defined as coronary disease),thus defined as gold standard.The diagnostic efficacy of HG and Ad was compared.Vital signs,routine blood and urine tests,blood biochemical items and side effects were documented for evaluation of procedure safety.Two-sample t test,x2 or Fisher's exact test,and Kappa test were used.Results A total of 109 patients completed the trim and CAG.The diagnostic sensitivity,specificity,accuracy,positive predictive value,negative predictive value of HG MPI were 56.1％ (32/57),78.8％ (41/52),67.0％(73/109),74.4％ (32/43) and 62.1％ (41/66),respectively,which were not significantly different from those ofAd MPI (52.6％ (30/57),82.7％ (43/52),67.0％ (73/109),76.9％ (30/39) and 61.4％(43/70) ;x2 =0-0.2476,all P＞0.05).The sensitivity of HG vs Ad MPI in the diagnosis of single-,double-and triple-vessel ischemia was 29.6％ (8/27) vs 22.2％ (6/27),64.7％ (11/17) vs 64.7％ (11/17)and 100％ (13/13) vs 100％ (13/13),respectively.The concordance between HG and Ad for the detection of LAD,LCX and RCA ischemia was 95.41％ (104/109),97.25％ (106/109) and 97.25％ (106/109) (Kappa=0.8905,0.8420 and 0.8874).HG did not induce significant systolic blood pressure change during or after administration.Both HG and Ad could induce temporary decrease of diastolic blood pressure.Either HG or Ad induced significantly increased HR during administration and 5 min after administration.The clinical laboratory profile (hematology,serum chemistry,and urinalysis) was either normal or with no significant change.A total of 176 side effects (e.g,dyspnea,short breath,palpitation,dizziness,headache) were found related to HG (69.2％,83/120) and Ad (77.5％,93/120) administration (x2=2.1307,P＞0.05),which were mostly mild and transient.Conclusion HG is a safe and effective pharmacological stress test agent as compared to adenosine for the detection of CAD with SPECT perfusion imaging.