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The cardiac MRI substudy to ongoing telmisartan alone and in combination with ramipril global endpoint trial/telmisartan randomized assessment study in ACE-intolerant subjects with cardiovascular disease: analysis protocol and baseline characteristics
Citation
Cowan, BR and Young, AA and Anderson, C and Doughty, RN and Krittayaphong, R and Lonn, E and Marwick, TH and Reid, CM and Sanderson, JE and Schmieder, RE and Teo, K and Wadham, AK and Worthley, SG and Yu, C-M and Yusuf, S and Jennings, GL, The cardiac MRI substudy to ongoing telmisartan alone and in combination with ramipril global endpoint trial/telmisartan randomized assessment study in ACE-intolerant subjects with cardiovascular disease: analysis protocol and baseline characteristics, Clinical Research in Cardiology, 98, (7) pp. 421-433. ISSN 1861-0684 (2009) [Refereed Article]
Copyright Statement
Copyright 2009 Springer Verlag
DOI: doi:10.1007/s00392-009-0014-4
Abstract
Background The ONTARGET and TRANSCEND clinical
trials were designed to investigate the cardioprotective
effects of telmisartan 80 mg and ramipril 10 mg, alone and
in combination, in patients at high risk of cardiovascular
disease. Cardiac MRI enables investigation of mechanistic
effects of these agents on cardiac structural and functional
variables. Here, we report the design, analysis protocol,
reproducibility and relevant quality control procedures, and
baseline patient characteristics of the ONTARGET/
TRANSCEND cardiac MRI substudy. MRI was undertaken
in 330 subjects enrolled in ONTARGET, and 38
subjects in TRANSCEND, across eight centers in six
countries. Analyses were performed by two independent analysts using guide-point modeling. Cases with discrepancies
in LV mass (LVM) of >5% were independently
reanalyzed. Cases with discrepancies in end-diastolic volume
(EDV) of >5%, or end-systolic volume (ESV) of >12%,
were then reconciled by consensus.
Results Baseline characteristics were broadly similar to the main ONTARGET/TRANSCEND trials, except for a higher frequency of coronary artery disease and Asian ethnicity in the substudy. Reproducibility of MRI analyses (mean ± SD) were 2.8 ± 3.7 ml in EDV,-0.3 ± 3.6 ml in ESV, 3.1 ± 3.3 ml in SV, 1.1 ± 1.8% in EF, and 0.4 ± 4.5 g in LVM. Subgroup analyses revealed increased ESV and LVM, and reduced EF, in subjects with a history of either coronary artery disease or myocardial infarction.
Conclusions The ONTARGET/TRANSCEND cardiac MRI substudy protocol provides for a reliable assessment of the effects of telmisartan and ramipril, alone and in combination, on cardiac structural and functional parameters over a 2-year follow-up period.
Results Baseline characteristics were broadly similar to the main ONTARGET/TRANSCEND trials, except for a higher frequency of coronary artery disease and Asian ethnicity in the substudy. Reproducibility of MRI analyses (mean ± SD) were 2.8 ± 3.7 ml in EDV,-0.3 ± 3.6 ml in ESV, 3.1 ± 3.3 ml in SV, 1.1 ± 1.8% in EF, and 0.4 ± 4.5 g in LVM. Subgroup analyses revealed increased ESV and LVM, and reduced EF, in subjects with a history of either coronary artery disease or myocardial infarction.
Conclusions The ONTARGET/TRANSCEND cardiac MRI substudy protocol provides for a reliable assessment of the effects of telmisartan and ramipril, alone and in combination, on cardiac structural and functional parameters over a 2-year follow-up period.
Item Details
| Item Type: | Refereed Article |
|---|---|
| Research Division: | Biomedical and Clinical Sciences |
| Research Group: | Cardiovascular medicine and haematology |
| Research Field: | Cardiology (incl. cardiovascular diseases) |
| Objective Division: | Health |
| Objective Group: | Clinical health |
| Objective Field: | Clinical health not elsewhere classified |
| UTAS Author: | Marwick, TH (Professor Tom Marwick) |
| ID Code: | 90770 |
| Year Published: | 2009 |
| Web of Science® Times Cited: | 9 |
| Deposited By: | Menzies Institute for Medical Research |
| Deposited On: | 2014-04-23 |
| Last Modified: | 2014-05-22 |
| Downloads: | 0 |
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