Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05509010
Other study ID # APOLLO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 2027

Study information

Verified date August 2022
Source National Heart Centre Singapore
Contact Associate Professor Zhong Liang
Phone +65 6704 2237
Email zhong.liang@nhcs.com.sg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall aim is to build an AI driven national Platform for CT cOronary angiography for clinicaL and industriaL applicatiOns (APOLLO) for automated anonymization, reporting, Agatston scoring and plaque quantification in CAD. It is a "one-stop" platform spanning diagnosis to clinical management and prognosis, and aid in predicting pharmacotherapy response.


Description:

Coronary artery disease (CAD), a blockage of the blood vessels, affects 6% of the general population and up to 20% of those over 65 years of age. CAD is a leading cause of cardiac mortality in Singapore and worldwide, with 19% of deaths in Singapore due to CAD (MOH website). Numbers of CAD cases are increasing due to ageing and the higher prevalence of contributary diseases such as diabetes. Computed Tomography Coronary Angiography (CTCA) is the first-line investigation for CAD as indicated by the National Institute for Clinical Excellence (NICE) guidelines. Recent Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) and Scottish Computed Tomography of the Heart (SCOT-HEART) trials support CTCA as the dominant means for evaluating coronary anatomy and physiology as it increases diagnostic certainty, improves efficiency of triage to invasive catheterization and reduces radiation exposure when compared to functional stress testing. Currently, CAD report generation requires 3-6 hours of a CT specialist's time to annotate scans, with inter-observer variability of 20%. In addition, there is no effective singular toolkit to analyse Agatston scores (a measure of calcified CAD), severity of stenosis, and plaque characterisation. These problems have severely constrained the effectiveness of CTCA as a diagnostic and research tool. The investigators plan to build upon Singapore's competitive advantages in artificial intelligence (AI) to provide a solution to these gaps.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age =21 years old 2. Signed informed consent 3. Clinically indicated for evaluation by CTCA Exclusion Criteria: 1. Individuals unable to provide informed consent 2. Known complex congenital heart disease 3. Planned invasive angiography for reasons other than CAD 4. Non-cardiac illness with life expectancy < 2 years 5. Pregnancy 6. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device 7. Cardiac event and/or coronary revascularization (percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG) and/or valvular repair/replacement prior to CTCA 8. Glomerular Filtration Rate = 30mL/min 9. Known allergy to iodinated contrast agent 10. Contraindications to beta blockers or nitroglycerin or adenosine

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CTCA
CTCA is performed as part of routine care procedure.

Locations

Country Name City State
Singapore National Heart Centre Singapore Singapore
Singapore National University Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
National Heart Centre Singapore Agency for Science, Technology and Research

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary AI precision toolkits: AI stenosis reporting Stenosis reporting: Severity of stenosis and accurate anatomical localization of stenosis.
The significance of a stenosis is determined by visual estimation of the maximal grade of luminal narrowing caused by the plaque. As recommended in SCCT guideline (Leipsic et al., 2014) , coronary stenosis can be graded as minimal, mild, moderate, severe and total occluded separately. Following the guideline, a stenosis will be classified as obstructive and non-obstructive. The location of the stenosis uses the SCCT model (Leipsic et al., 2014)
baseline
Primary AI precision toolkits: Agatston scoring Agatston scoring: Agatston scoring of calcified plaque. As recommended in SCCT clinical practical guidelines (Leipsic et al., 2014), Agatston scoring programs generally identify pixels that exceed 130 HU as a level corresponding to calcium on a non-contrast study (Agatston et al., 1990) . The reader needs to identify each lesion discrete calcific focus) in each vessel distribution. The summed score for each vessel is generated by the scoring program based on an area-density (Agatston score) (Agatston et al., 1990) measurement of each calcified focus. The total coronary Agatston score is the sum of all calcified lesions in all coronary beds. baseline
Primary AI precision toolkits: Plaque Plaque analysis: Plaque volume, burden, type and anatomical locations. Coronary segmentation and plaque analysis is performed for segments with diameter =1.5 mm. Location of plaque uses the SCCT model (Leipsic et al., 2014). For each plaque, the reader marks its start-and end-points, quantifies plaque area,volume and plaque burden, and specifies its type (non-calcified, calcified, or mixed) (Achenbach et al., 2004) . Additionally, non-calcified plaque can be further divided into low attenuation plaque (LAP). A HU <30 will signify LAP and >30 will signify non-LAP. baseline
Primary AI precision toolkits: EAT analysis EAT analysis: Total volume and anatomical locations. EAT and pericardial adipose tissue (PAT) are metabolically active fat surrounding the coronary artery and the heart, being associated with increased risk of cardiovascular disease (Villasante et al, 2019) . EAT can be quantified on non-contrast CT scans. The annotations on the CT scans are obtained by manually drawing the pericardium first to define the region. EAT is identi?ed using the adipose tissue attenuation references between -190 and -30 HU (Oikonomou et al., 2018) . Due to the CT scan noise and changing of attenuation, the HU value of fat can vary, so the final EAT region is verified by an experienced radiologist or cardiologist. baseline
Secondary AI outcome analysis 1. Mortality (All-cause and/or cardiovascular) one to five years from baseline
Secondary AI outcome analysis Major-adverse cardiovascular events (myocardial infarction, stroke, heart failure, revascularisation, arrhythmias, etc) one to five years from baseline
Secondary AI outcome analysis Re-hospitalisation one to five years from baseline
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A