Symptomatic Trial of Angina Assessment Prior to Revascularization

NCT ID: NCT04280575

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-16

Study Completion Date

2023-05-01

Brief Summary

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The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.

Detailed Description

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Conditions

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Coronary Artery Disease Angina, Stable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous coronary intervention

Coronary artery stenting for stable angina

Intervention Type PROCEDURE

Other Intervention Names

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PCI

Eligibility Criteria

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Inclusion Criteria

1. Angina or angina-equivalent symptoms
2. Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
3. Referred for percutaneous coronary intervention for treatment of stable angina

Exclusion Criteria

1. Age younger than 18
2. Age older than 85
3. Recent acute coronary syndrome
4. Multivessel coronary artery disease
5. Previous coronary artery bypass graft surgery
6. Significant left main stem coronary disease
7. Chronic total occlusion in the target vessel
8. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
9. Contraindication to antiplatelet therapy
10. Contraindication to adenosine infusion
11. Severe valvular disease
12. Severe LV systolic impairment
13. Severe respiratory disease
14. Life expectancy less than 2 years, pregnancy, unable to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust

Basildon, Essex, United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Simader FA, Mohsin M, Ganesananthan S, Nowbar AN, Chotai S, Sen S, Petraco R, Nijjer SS, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham G, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention. J Am Coll Cardiol. 2024 Jul 2;84(1):1-12. doi: 10.1016/j.jacc.2024.04.001. Epub 2024 May 14.

Reference Type DERIVED
PMID: 38752902 (View on PubMed)

Other Identifiers

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19HH5060

Identifier Type: -

Identifier Source: org_study_id

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