| Title: |
High prevalence of ST-elevation, early repolarization, and left ventricular hypertrophy during the eligibility assessment for an HIV vaccine trial in young, healthy Tanzanians |
| Authors: |
Mann, P; Munseri, P; Missanga, M; Lwakatare, J; Janabi, M; Kapesa, E; Robb, ML; Hoelscher, M; McCormack, S; Bakari, M; Maboko, L; Sandström, E; Kroidl, A |
| Source: |
Clinical Trials and Regulatory Science in Cardiology , 26 (2017) |
| Publication Year: |
2017 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
ECG; AfricaST-elevation; Early repolarization; MVA vaccine |
| Description: |
BACKGROUND: Vaccinia based immunizations have caused myo/pericarditis and vaccine study volunteers are monitored by ECG. We report ECG outcome obtained during the screening period for an HIV vaccine trial. METHODS: ECG was performed in healthy Tanzanian volunteers. ECG abnormalities and findings interfering with the interpretation of myo/pericarditis were subject to study ineligibility. We determined the prevalence of left ventricular hypertrophy (LVH) defined by the Sokolow-Lyon (SL) or the Cornell index, ST-elevations and early repolarization (ERP) in association with gender, age, BMI and body height by regression analysis adjusted for gender and age. RESULTS: In 257 volunteers (median age 23 years, 63% males) overall positivity for LVH defined by SL or Cornell criteria was seen in 20.6% and 3.5%, ST-elevations ≥ 0.1 mV or ≥ 0.2 mV in 77.8% and 38.1%, and ERP in 23.4%. Positive SL criteria were associated with male gender (PR 7.84, p < 0.001) and lower age (PR 0.70, p = 0.002), and associated with increased body height and lower BMI in univariate analysis. Positive Cornell criteria were only associated with lower age (PR 0.44, p = 0.010). ST-elevations ≥ 0.2 mV were associated with male gender (PR 8.05, p < 0.001) and lower age (PR 0.81, p = 0.003), and ERP with male gender (PR 2.86, p < 0.001). Vaccine study ineligibility due to ECG findings was concluded in 22.1% of the screening population. CONCLUSIONS: High prevalence of LVH according to SL in association with ST-elevation and ERP is especially found in young and male Africans. ECG variations need to be considered for eligibility criteria in studies investigating potential cardiotoxic agents in Africa. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/1560728/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/1560728/1/McCormack_1-s2.0-S2405587516300348-main.pdf; https://discovery.ucl.ac.uk/id/eprint/1560728/ |
| Rights: |
open |
| Accession Number: |
edsbas.EA0B4D48 |
| Database: |
BASE |