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

Cowan, Brett R., Young, Alistair A., Anderson, Craig, Doughty, Robert N., Krittayaphong, Rungroj, Lonn, Eva, Marwick, Thomas H., Reid, Chris M., Sanderson, John E., Schmieder, Roland E., Teo, Koon, Wadham, Angela K., Worthley, Stephen G., Yu, Cheuk-Man, Yusuf, Salim and Jennings, Garry L. (2009) 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: 421-433. doi:10.1007/s00392-009-0014-4


Author Cowan, Brett R.
Young, Alistair A.
Anderson, Craig
Doughty, Robert N.
Krittayaphong, Rungroj
Lonn, Eva
Marwick, Thomas H.
Reid, Chris M.
Sanderson, John E.
Schmieder, Roland E.
Teo, Koon
Wadham, Angela K.
Worthley, Stephen G.
Yu, Cheuk-Man
Yusuf, Salim
Jennings, Garry L.
Title 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
Journal name Clinical Research in Cardiology   Check publisher's open access policy
ISSN 1861-0684
Publication date 2009-07-01
Sub-type Article (original research)
DOI 10.1007/s00392-009-0014-4
Open Access Status
Volume 98
Issue 7
Start page 421
End page 433
Total pages 13
Place of publication Germany
Publisher Dr. Dietrich Steinkopff Verlag
Language eng
Formatted 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.
Keyword Cardiac MRI
Left-ventricular mass
Ontarget
Transcend
Trials
Telmisartan
Ramipril
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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Created: Thu, 03 Sep 2009, 17:51:29 EST by Mr Andrew Martlew on behalf of School of Medicine