Virtual Coronary Physiology: an Angiogram is All You Need

NCT02437734 | Completed

• 1 other identifier: STH16467
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Disease in coronary arteries kills more people in the UK than any other cause. The investigators have developed a computer system ('VIRTU') which predicts blood pressure changes inside coronary arteries. This is important because;

• Doctors make better decisions regarding when and how to treat patients with coronary artery disease if they have these blood pressure measurements
• Currently, Doctors have to insert a metal wire inside the heart to measure artery pressures which is time-consuming and requires special equipment, staff, training and medicines. Although this invasive technique saves lives and money, more than 95% of patients do not receive the procedure or the benefits it provides. VIRTU provides a solution to this problem since it only needs X-ray pictures and does not require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and works but needs improving before it can be used in all patients. GOALS: Following, and compared with, our pilot project ((Modelling the significance of coronary artery disease, STH 15740) to:
• Improve VIRTU's accuracy.
• Improve VIRTU's speed.
• Test VIRTU in patients with more complicated coronary disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Intracoronary blood pressures

  2 hours

Study Arms (1)

Coronary angiography

OTHER

Selected patients will be asked to undergo Coronary angiography with cardiac magnetic resonance imaging before and after Percutaneous Coronary Intervention. Clinical data collection will happen over a 30 month period.

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

A phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography.

Coronary angiography

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable symptoms of coronary ischemia
• Coronary angiographic findings of significant or borderline coronary lesions of any morphology
• Potentially suitable for PCI

You may not qualify if:

• Critical ischemia
• Significant valvular heart disease
• Bleeding diathesis
• Terminal cancer
• Pregnancy 6. Lack of informed consent
• Chronic total occlusion of target vessel
• Acute presentation in the previous 60 days
• Intolerance of adenosine, nitrate, iodine based contrast media
• Inability to take dual antiplatelet therapy
• Target vein graft.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Wellcome Trust: collaborator

Study Sites (1)

Northern General Hospital

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nana Theodorou

  STH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: August 13, 2013
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

GB (1)