| Protocol ID | NCT03217240 |
| Registration Date | 2017-07-14 |
| Status | Unknown Status |
| Sponsor | National Heart Centre Singapore |
| Country | Singapore |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2017-06-05 |
| Last Patient Out | 2019-08-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 12 Years - 80 Years |
NCT03217240
Integrated Computational modelIing of Right Heart Mechanics and Blood Flow Dynamics in Congenital Heart Disease ("INITIATE")
| Field |
OPENAI
gpt-4o Thinking: o3 3423ms / 9600 tok |
GLM
glm-5.1 7461ms / 9802 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 6003ms / 11172 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | cardiac | cardiac | cardiac | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The trial involves outpatient procedures such as cardiac magnetic resonance and exercise tests, likely delivered in an outpatient clinic or similar setting, not requiring hospitalization.
|
other
hospital
shaky reasoning✓ Unanimous
Initial: hospital
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an observational study involving cardiac MRI, cardiopulmonary exercise testing, and blood sampling conducted at outpatient facilities rather than requiring hospital admission.
|
OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → yes → no
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The intervention includes a cardiopulmonary exercise test, which is a physical activity assessment and does not fit into any of the specified categories.
Thinking: no — The study’s interventions (MRI imaging and exercise testing) involve medical devices, placing them in the predefined “device” category rather than the residual “other” category.
|
yes
yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The clinical trial utilizes a device (Cardiac Magnetic Resonance) and diagnostic/screening procedures (Cardiopulmonary Exercise Test, Blood Sampling) which disqualify it from the residual 'other' category.
|
yes
yes → yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The study involves exercise testing (cardiopulmonary exercise test) as one of its interventions, which is a physical/exercise-based intervention that doesn't fit into any of the specified categories.
Thinking: yes — This is an observational study developing computational models and diagnostic assessment methods, not testing any therapeutic intervention from the standard categories.
|
|
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on imaging and computational modeling of heart mechanics with no explicit mention of cost-effectiveness, healthcare utilization, or cost analysis.
Thinking: no — The study focuses on imaging-based assessment of right-heart mechanics without measuring costs, resource use, or economic outcomes.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on developing an imaging and computational platform for cardiac mechanics and function, with only a brief mention of increasing visit costs rather than performing a formal cost or healthcare utilization analysis.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study explicitly mentions that "considering inflation to visit costs and added image technology for diagnosis, the cost of each patient is expected to increase," indicating cost considerations are part of the research framework.
Thinking: no — This is an observational imaging study developing computational models for heart mechanics assessment without any cost-effectiveness, healthcare utilization, or economic outcomes measured.
|
OK |
| outcome_other |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome includes the development of a comprehensive research and development platform for clinical decision-making and surgical planning, which does not fit solely into symptom/QoL/dignity/cost categories.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome focuses on developing a biomedical engineering platform to assess RV mechanics and blood flow, which is not covered by the symptom/QoL/dignity/cost categories.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome is developing a computational biomedical engineering platform and research database, which is a feasibility/methodology outcome not related to symptom/QoL/dignity/cost.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |