Trial Outcomes & Findings for Training-induced Increased Left Ventricular Trabeculation (NCT NCT02568072)
NCT ID: NCT02568072
Last Updated: 2021-08-05
Results Overview
Measured on echocardiography and cardiac magnetic resonance: 1. Echocardiographic measure of compacted myocardial tissue (systole) - Jenni Compacted layer measurement (cm) 2. Cardiac magnetic resonance measure of compacted myocardial tissue (diastole) - Petersen Compacted layer measurement (cm)
COMPLETED
120 participants
Baseline and 7 months
2021-08-05
Participant Flow
Participant milestones
| Measure |
Study Group
120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Study Group
120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
|
|---|---|
|
Overall Study
Unavailable for appointment
|
23
|
|
Overall Study
Unable to contact
|
3
|
|
Overall Study
Diagnosis of Long QT Syndrome
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Sustained injury, marathon not run
|
24
|
Baseline Characteristics
Training-induced Increased Left Ventricular Trabeculation
Baseline characteristics by cohort
| Measure |
Study Group
n=68 Participants
120 subjects recruited into study. 18-35 years old and had never run a marathon distance previously. Individuals were excluded if they had pre-existing cardiovascular disease during preliminary investigations or contraindication to cardiac magnetic resonance (CMR).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 3.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
68 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 monthsPopulation: One subject did not undergo cardiac magnetic resonance imaging post marathon due to first trimester pregnancy 68 Participants underwent the "Jenni Compacted layer measurement (cm)" and 67 Participants underwent the "Petersen Compacted layer measurement (cm)"
Measured on echocardiography and cardiac magnetic resonance: 1. Echocardiographic measure of compacted myocardial tissue (systole) - Jenni Compacted layer measurement (cm) 2. Cardiac magnetic resonance measure of compacted myocardial tissue (diastole) - Petersen Compacted layer measurement (cm)
Outcome measures
| Measure |
Baseline
n=68 Participants
Study participants with places in the 2016 London Marathon assessed prior to training
|
7 Months
n=67 Participants
Study participants evaluated after completing the 2016 London Marathon
|
|---|---|---|
|
Thickness of Compacted Myocardial Tissue (cm)
Jenni Compacted layer measurement (cm)
|
0.8 cm
Interval 0.7 to 1.0
|
0.85 cm
Interval 0.7 to 1.0
|
|
Thickness of Compacted Myocardial Tissue (cm)
Petersen Compacted layer measurement (cm)
|
0.53 cm
Interval 0.45 to 0.63
|
0.56 cm
Interval 0.48 to 0.64
|
PRIMARY outcome
Timeframe: Baseline and 7 monthsPopulation: One subject did not undergo cardiac magnetic resonance imaging post marathon due to first trimester pregnancy 68 Participants underwent the "Jenni Compacted layer measurement (cm)" and 67 Participants underwent the "Petersen Compacted layer measurement (cm)"
Measured on echocardiography and cardiac magnetic resonance: 1. Echocardiographic measure of non-compacted myocardial tissue (systole) - Jenni Non-Compacted layer measurement (cm) 2. Cardiac magnetic resonance measure of non-compacted myocardial tissue (diastole) - Petersen Non-Compacted layer measurement (cm)
Outcome measures
| Measure |
Baseline
n=68 Participants
Study participants with places in the 2016 London Marathon assessed prior to training
|
7 Months
n=67 Participants
Study participants evaluated after completing the 2016 London Marathon
|
|---|---|---|
|
Thickness of Non-compacted Myocardial Tissue (cm)
Petersen Non-Compacted layer measurement (cm)
|
0.65 cm
Interval 0.44 to 0.84
|
0.58 cm
Interval 0.43 to 0.73
|
|
Thickness of Non-compacted Myocardial Tissue (cm)
Jenni Non-Compacted layer measurement (cm)
|
0.8 cm
Interval 0.5 to 1.0
|
0.8 cm
Interval 0.6 to 1.0
|
PRIMARY outcome
Timeframe: Baseline and 7 monthsPopulation: One subject did not undergo cardiac magnetic resonance imaging post marathon due to first trimester pregnancy 67 Participants underwent the "Fractal Dimension analysis" with paired results at baseline and at 7 months.
Measured on cardiac magnetic resonance, dimensionless unit and measure of endomyocardial boarder complexity. The higher the value the greater the endocardial boarder complexity and therefore the more trabeculation. Two measurements were made: 1. Captur et al. Global mean left ventricular fractal dimension 2. Captur et al. Maximum apical fractal dimension These values are between 1 and 2. Binarisation eliminates pixel detail originating from the blood pool. The edge image is covered by a series of grids. The minimum size is set to 2 pixels. The maximum size of the grid series is dictated by the dimensions of the bounding box, referring to the smallest rectangle that encloses the foreground pixels. Through the implementation of this 2D box-counting approach, a fractal output of between 1 and 2 is expected. The log-lot plot (e) produces a good fit using linear regression and yields a gradient equivalent to - FD (1.363).
Outcome measures
| Measure |
Baseline
n=68 Participants
Study participants with places in the 2016 London Marathon assessed prior to training
|
7 Months
n=67 Participants
Study participants evaluated after completing the 2016 London Marathon
|
|---|---|---|
|
Myocardial Fractal Dimension
Captur et al. Global mean left ventricular fractal dimension
|
1.20 unitless
Standard Deviation 0.06
|
1.19 unitless
Standard Deviation 0.05
|
|
Myocardial Fractal Dimension
Captur et al. Maximum apical fractal dimension
|
1.36 unitless
Standard Deviation 0.09
|
1.36 unitless
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline and 7 monthsPopulation: Three subjects did not have complete cardiopulmonary exercise testing results post marathon, two due to injuries sustained and one due to equipment failure. 68 Participants underwent the cardiopulmonary exercise test at baseline but 65 Participants underwent the cardiopulmonary exercise test at 7 months.
peak oxygen consumption measured by cardiopulmonary exercise testing on a semi-recumbent cycle ergometer. Reported standardised to age, gender, height and weight in ml/kg/min
Outcome measures
| Measure |
Baseline
n=68 Participants
Study participants with places in the 2016 London Marathon assessed prior to training
|
7 Months
n=65 Participants
Study participants evaluated after completing the 2016 London Marathon
|
|---|---|---|
|
Increase in Peak Oxygen Consumption on Cardiopulmonary Exercise Testing After Training
|
37.9 ml/kg/min
Standard Deviation 6.3
|
38.4 ml/kg/min
Standard Deviation 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 7 monthsPopulation: As no changes in remodelling data were demonstrated in the primary analysis, it was felt by the primary supervisor that NTproBNP levels would not be expected to change and further investigation and expense would not be of value. The initial hypothesis that NTproBNP levels would change was predicated on the assumption that remodelling changes would be found and correlation with biomarker elevation would have yielded some insights had remodelling occurred.
Serum biomarker level. No outcome data reported as during the conduct of the study remodelling was not seen from baseline to post-marathon study time-points and therefore NTproBNP levels were expected to remain unchanged and would not provide any additional value in the study and so was not undertaken.
Outcome measures
Outcome data not reported
Adverse Events
Study Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place