Prospective Identification of High-risk Coronary Plaques Through Non-invasive Imaging

NCT02347306 | Unknown

• 1 other identifier: P01987 Protocol 1.0 September
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular disease remains the leading cause of death worldwide. Identifying individual patients at risk of a suture adverse events, including myocardial infractions (heart attacks), remains a major diagnostic challenge. Recent studies have shown that coronary plaques responsible for hear attack are composed of a large lipid core with a thin overlying fibrous cap. Although these features can be identified using invasive imaging modalities, non-invasive imaging options remain limited due to their poor spatial resolution. Recently the investigators have developed and validated a novel tool that will allow us to characterise coronary plaque composition based on dual source CT images. Our aim is to assess this tool within a cohort of patients who have already undergone a coronary CT as part of a previous study.

Conditions

Coronary Plaques

Outcome Measures

Primary Outcomes (1)

• CT-defined TCFA association with future adverse cardiovascular events

  7 years post surgery

Study Arms (1)

cohort of patients with suspected coronary artery disease

a cohort of patients with suspected coronary artery disease going forward for conventional angiography and (2) whether CT-TCFA is associated with future adverse cardiovascular events.

Other: Telephone interview

Interventions

Telephone interview OTHER

cohort of patients with suspected coronary artery disease

Eligibility Criteria

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

Study Population

This study will be an observational, retrospective, single center cohort study based at Papworth Hospital NHS Trust, including up to a maximum of 100 patients. The patients have already been identified through their participation in a previous research study, as stated above. Additional inclusion criteria are; age \>18 years and the ability to provide informed consent. The only exclusion criterion is the inability of the participant to provide informed consent.

You may qualify if:

• Age \>18 years
• The ability to provide informed consent.
• Previously part of CTA accuracy validation study

You may not qualify if:

• The inability of the participant to provide informed consent

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 27, 2015

Record last verified: 2015-01