NCT04280575

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

February 13, 2020

Last Update Submit

September 21, 2023

Conditions

Coronary Artery DiseaseAngina, Stable

Outcome Measures

Primary Outcomes (1)

  • Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery

    Similarity Score (1-10) (Higher Score = Better Outcome)

    30 Days

Secondary Outcomes (10)

  • Change in angina symptom score

    30 Days

  • Change in treadmill exercise time

    30 Days

  • Change in treadmill time to chest pain

    30 Days

  • Angina severity as assessed by Canadian Cardiovascular Society Class

    30 Days

  • Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.

    30 Days

  • +5 more secondary outcomes

Interventions

Percutaneous coronary interventionPROCEDURE

Coronary artery stenting for stable angina

Also known as: PCI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with single-vessel coronary artery disease with symptoms of stable angina

You may qualify if:

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

You may not qualify if:

  • Age younger than 18
  • Age older than 85
  • Recent acute coronary syndrome
  • Multivessel coronary artery disease
  • Previous coronary artery bypass graft surgery
  • Significant left main stem coronary disease
  • Chronic total occlusion in the target vessel
  • Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
  • Contraindication to antiplatelet therapy
  • Contraindication to adenosine infusion
  • Severe valvular disease
  • Severe LV systolic impairment
  • Severe respiratory disease
  • Life expectancy less than 2 years, pregnancy, unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust

Basildon, Essex, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (2)

  • Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Chotai S, Simader FA, Mohsin M, Salih A, Ganesananthan S, Bual N, Petraco R, Nijjer SS, Sen S, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham GJ, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. The Role of the Collateral Circulation in Stable Angina: An Invasive Placebo-Controlled Study. Circulation. 2025 Dec 2;152(22):1541-1551. doi: 10.1161/CIRCULATIONAHA.125.074687. Epub 2025 Oct 27.

    PMID: 41144984DERIVED

  • 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.

    PMID: 38752902DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum troponin samples

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, Stable

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 21, 2020

Study Start

January 16, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)