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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.
Clin Res Cardiol. 2009 Jul; 98(7):421-33.CR

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.

Authors+Show Affiliations

Auckland MRI Research Group, University of Auckland, Auckland, New Zealand.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19347385

Citation

Cowan, Brett R., et al. "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 : Official Journal of the German Cardiac Society, vol. 98, no. 7, 2009, pp. 421-33.
Cowan BR, Young AA, Anderson C, et al. 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. Clin Res Cardiol. 2009;98(7):421-33.
Cowan, B. R., Young, A. A., Anderson, C., Doughty, R. N., Krittayaphong, R., Lonn, E., Marwick, T. H., Reid, C. M., Sanderson, J. E., Schmieder, R. E., Teo, K., Wadham, A. K., Worthley, S. G., Yu, C. M., Yusuf, S., & Jennings, G. 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 : Official Journal of the German Cardiac Society, 98(7), 421-33. https://doi.org/10.1007/s00392-009-0014-4
Cowan BR, et al. 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. Clin Res Cardiol. 2009;98(7):421-33. PubMed PMID: 19347385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Cowan,Brett R, AU - Young,Alistair A, AU - Anderson,Craig, AU - Doughty,Robert N, AU - Krittayaphong,Rungroj, AU - Lonn,Eva, AU - Marwick,Thomas H, AU - Reid,Chris M, AU - Sanderson,John E, AU - Schmieder,Roland E, AU - Teo,Koon, AU - Wadham,Angela K, AU - Worthley,Stephen G, AU - Yu,Cheuk-Man, AU - Yusuf,Salim, AU - Jennings,Garry L, Y1 - 2009/04/04/ PY - 2008/12/10/received PY - 2009/03/17/accepted PY - 2009/4/7/entrez PY - 2009/4/7/pubmed PY - 2009/10/24/medline SP - 421 EP - 33 JF - Clinical research in cardiology : official journal of the German Cardiac Society JO - Clin Res Cardiol VL - 98 IS - 7 N2 - 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. SN - 1861-0692 UR - https://www.unboundmedicine.com/medline/citation/19347385/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_ L2 - https://dx.doi.org/10.1007/s00392-009-0014-4 DB - PRIME DP - Unbound Medicine ER -