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Biomedical subjects

H Morales-Ballejo

Publications and source records attributed to H Morales-Ballejo.

6 recordsLinked to original sources

Transdermal nitroglycerin patch therapy improves left ventricular function and prevents remodeling after acute myocardial infarction: results of a multicenter prospective randomized, double-blind, placebo-controlled trial.

BACKGROUND: Nitrates are widely used in the treatment of angina in patients with acute myocardial infarction (AMI). Short-term administration prevents left ventricular (LV) dilation and infarct expansion. However, little information is available regarding their long-term effects on LV remodeling in patients surviving Q-wave AMI. METHODS AND RESULTS: This was a randomized, double-blind, placebo-controlled trial designed to investigate the long-term (6-month) efficacy of intermittent transdermal nitroglycerin (NTG) patches on LV remodeling in 291 survivors of AMI. Patients meeting entry criteria had baseline gated radionuclide angiography (RNA) followed by randomization to placebo or active NTG patches delivering 0.4-, 0.8-, or 1.6-mg/h. RNA was repeated at 6 months and 6.5 days after withdrawal of double-blind medication. The primary study end point was the change in end-systolic volume index (ESVI). Both ESVI and end-diastolic volume index (EDVI) were significantly reduced with 0.4-mg/h NTG patches (-11.4 and -11.6 mL/m2, respectively, P<.03). This beneficial effect was observed primarily in patients with a baseline LV ejection fraction < or =40% (deltaESVI, -31 mL/m2; deltaEDVI, -33 mL/m2; both P<.05) and only at the 0.4-mg/h dose. After NTG patch withdrawal, ESVI significantly increased but did not reach pretreatment values. CONCLUSIONS: Transdermal NTG patches prevent LV dilation in patients surviving AMI. The beneficial effects are limited to patients with depressed LV function and only at the lowest (0.4-mg/h) dose. Continued administration is necessary to maintain efficacy. Whether these remodeling effects confer a clinical or survival advantage will need to be addressed in an adequately powered cardiac event trial.

Administration, Cutaneous↗

Design of a randomized, placebo-controlled multicenter trial on the long-term effects of intermittent transdermal nitroglycerin on left ventricular remodeling after acute myocardial infarction. Transdermal Nitroglycerin Investigators Group.

Nitrates are widely used in the treatment of patients with ischemic heart disease and in those with angina following acute myocardial infarction. Short-term studies indicate that the administration of nitrates may prevent left ventricular (LV) dilation and infarct expansion. Animal models suggest that prolonged nitroglycerin use after infarction may limit LV remodeling similar to that observed with angiotensin-converting enzyme inhibitors. However, to date there have been no trials evaluating the effects of nitrates on LV volumes in patients surviving acute myocardial infarction. We therefore performed a randomized double-blind, placebo-controlled trial designed to investigate the long-term (6 month) efficacy of intermittent transdermal nitroglycerin patches on LV remodeling in 291 survivors of acute myocardial infarction. Patients were randomized to receive either placebo or a nitroglycerin patch that delivered 0.4, 0.8, or 1.6 mg/hour. Gated radionuclide angiography was used to assess serial changes in LV ejection and cardiac volumes. The baseline characteristics of the study population were similar in all 4 treatment groups. The study protocol and the main design-related issues are described.

Administration, Cutaneous↗

Transdermal nitroglycerin patch therapy reduces the extent of exercise-induced myocardial ischemia: results of a double-blind, placebo-controlled trial using quantitative thallium-201 tomography.

OBJECTIVES: This study prospectively evaluated whether transdermal nitroglycerin patches could limit the extent of exercise-induced left ventricular ischemia as assessed by quantitative thallium-201 tomography. BACKGROUND: Although antianginal medications are effective at reducing chest pain symptoms in patients with coronary artery disease, there is limited evidence that these agents can also reduce myocardial ischemia. METHODS: This was a randomized, double-blind, parallel, placebo-controlled trial evaluating nitroglycerin patch therapy in patients in stable condition with angiographic coronary artery disease and no previous myocardial infarction. All patients were weaned from antianginal agents and had a baseline symptom-limited treadmill test followed by thallium-201 tomography. Forty patients with perfusion defects involving > or = 5% of the left ventricle were randomized to receive either intermittent (12 h on/off) active nitroglycerin patch therapy (0.4 mg/h) or placebo. Exercise tomography was repeated a mean (+/- SD) of 6.1 +/- 1.8 days after randomization. RESULTS: Patients randomized to receive active patch therapy had a significant reduction in their total perfusion defect size (-8.9 +/- 11.1%) compared with placebo-treated patients (-1.8 +/- 6.1%, p = 0.04), which was most apparent in those with the largest (> or = 20%) baseline perfusion defects (-11.4 +/- 13.4% vs. 1.0 +/- 3.6%, respectively, p < 0.02). Furthermore, 7 (33%) of 21 patients receiving active therapy had a > or = 10% decrease in their perfusion defects compared with only 1 (5%) of 19 patients randomized to receive placebo (p = 0.002). Nitrate therapy did not significantly reduce heart rate, blood pressure or double product, indicating benefit through enhancement of coronary blood flow. CONCLUSIONS: Short-term, intermittent nitroglycerin patch therapy significantly reduces myocardial ischemia, particularly in patients with large ischemic perfusion defects. Thallium-201 tomography can be used to assess sequential changes in the extent of exercise-induced left ventricular ischemia.

Administration, Cutaneous↗

Septal Q wave in exercise testing: angiographic correlation.

A study of septal Q wave response in lead CM5 was carried out to evaluate its usefulness in predicting coronary artery disease. Q wave amplitude was measured in 50 patients with coronary artery disease and 50 normal subjects before and immediately after exercise. In the 100 patients evaluated with coronary angiography, the septal Q wave in lead, CM5 was smaller in patients with coronary artery disease than in normal subjects at rest (probability [p] less than 0.001) and immediately after exercise (p less than 0.001). An embryonic (0.5 mm) or absent Q wave in lead CM5 was significantly more frequent in patients with coronary artery disease than in normal subjects both at rest (76 versus 48 percent) and after exercise (82 versus 16 percent). The sensitivity for S-T depression was 52 percent, the specificity 74 percent and the predictive value 70 percent. The respective values for Q wave were 82, 88 and 87 percent. These differences were not significant (p less than 0.05). When either a positive S-T or Q wave response was used, the sensitivity increased to 92 percent (p less than 0.05), and the specificity and predictive values remained unchanged (p less than 0.01). An increase in Q wave amplitude with exercise identified a false positive S-T segment response to stress in 75 percent of cases. Absence of the Q wave in lead CM5 with S-T depression after identified a true positive response in 100 percent of cases. These findings suggest that low Q wave voltage and it failure to increase after exercise imply abnormal septal activation, reflecting loss of contraction associated with ischemia. This finding may be a useful marker for ischemia; the increase in the septal Q wave with exercise may be of value in identifying a false positive S-T segment response.

Coronary Angiography↗

Radionuclide angiographic correlation of the R wave, ejection fraction, and volume responses to upright bicycle exercise.

The change in the R wave and the response of the ejection fraction to upright bicycle stress testing with radionuclide angiographic studies were determined for 18 control subjects and 29 patients with coronary arterial disease (70 percent stenosis or more). In the control group, all had an increase in the ejection fraction from 64.8 +/- 7.7 to 75.7 +/- 9.4 percent with stress (P less than 0.01). All control subjects had a decrease in the R wave with exercise. In the group with coronary arterial disease, most patients had a decrease in the ejection fraction averaging from 63.5 +/- 10.9 to 58.6 +/- 12.8 percent (P less than 0.01). An appropriate response of the R wave and ejection fraction (decrease in R wave and increase in ejection fraction or increase in R wave and decrease in ejection fraction) occurred in 23 (79 percent) of 29 subjects (P less than 0.005). The sensitivity, specificity, and predictive value for the response of the ejection fraction were as follows: 83 percent (24/29); 100 percent (18/18); and 100 percent (24/24). Of the patients with coronary arterial disease and an increase in the R wave, 17 (94 percent) had multivessel disease, while six (55 percent) of 11 with a decrease in the R wave had multivessel disease (P less than 0.05). The systolic volume decreased in all control subjects by -15.9 +/- 8.6 units (P less than 0.01) and increased in most of the group with coronary arterial disease by 13.7 +/- 17.8 units (P less than 0.01) in response to stress. There were 20 of 29 patients (P less than 0.05) with an appropriate response of the R wave and systolic volume to stress (increase in R wave and systolic volume or decrease in both). The change in the R wave did not correlate with the change in the diastolic volume with stress (P greater than 0.05). Changes in the R wave with exercise correlate with the change in the ejection fraction (and hence ventricular function) and with the changes in systolic volume, which may be one of the mechanisms of the response of the R wave, suggesting that the change in the R wave is related to changes in contractility. Increase in the R wave with stress suggests multivessel coronary arterial disease.

Adult↗