Investigation of the Role of Hemodynamics in Re-stenosis of CABG Patients

NCT02791087 | Completed

• 1 other identifier: 2013/366/C
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

CFD simulations in this study provide detailed hemodynamics information, which cannot be obtained from cardiac images alone. The investigators hypothesize that our proposed simulations will provide strong correlation between hemodynamic parameters, such as WSSG and SPA, and clinically identified graft stenosis. These correlations will allow the investigators to identify the future patients at high risk of graft stenosis and lead to future researches on optimizing and refining surgical plans, such as finding optimal proximal and distal anastomoses locations, optimal graft length and diameter, which could lead to improved longevity of the graft. Once CFD coupled shape optimizer is validated, it could be part of the surgical simulator to help in training the next generation physicians. It could provide new viewpoints for assessing whether some modified surgical techniques are better or not. It could also aid in designing and evaluating the vascular medical devices, including stent, artificial graft, and etc., which would lead to better surgical outcome.

Conditions

Coronary Artery Disease; Stable Angina; Unstable Angina

Outcome Measures

Primary Outcomes (1)

• Evidence of allergic reaction due to CTA scan contrast

  Within first day after scan

Study Arms (2)

Coronary Artery Disease for CABG

Patients undergoing or underwent Coronary Bypass Surgery with at least one saphenous vein graft. Intra-operative graft flow rate measurement will be done during CABG surgery.

Other: Computed Tomography Angiography; Other: Intra-operative graft flow rate measurement

Stable/Unstable Angina

Patients with no known history of coronary artery disease undergoing Computed Tomography Angiography scan due to stable/Unstable Angina.

Other: Computed Tomography Angiography

Interventions

Computed Tomography Angiography OTHER

The CTA is non-invasive and is used commonly for patients who have chest pain to assess the coronary artery disease, prior to the more invasive coronary angiogram.

Coronary Artery Disease for CABG; Stable/Unstable Angina

Intra-operative graft flow rate measurement OTHER

This procedure involves the insertion of a Medistim Ultrasound Transit Time Flow Probe into the graft vessel to measure its flow rate. This technique is commonly used for evaluating graft opening during CABG surgery.

Coronary Artery Disease for CABG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential patients scheduled for Coronary Bypass Surgery identified at NHCS cardiology inpatient and patients with stable/unstable angina from cardiology inpatient and outpatient clinic.

You may qualify if:

• Aged 21-80.
• Undergoing or underwent CABG with at least one saphenous vein graft. (Only for recruitment of CABG patients)
• No known history of coronary artery disease (only for recruitment of volunteers with Stable/unstable angina).

You may not qualify if:

• Individuals unable to provide informed consent.
• Non-cardiac illness with life expectancy \<2 years.
• Pregnant state.
• Allergy to iodinated contrast.
• Significant arrhythmia; heart rate ≥ 100 beats/min; systolic blood pressure ≤90 mmHg.
• Renal dysfunction(Glomerular filtration rate (GFR) \<30 mL/min/1.73m2).
• Contraindication to beta blockers or nitroglycerin.
• Canadian Cardiovascular Society class IV angina.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Junmei Zhang

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 6, 2016
• Study Start: June 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 7, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)