NCT05841199

Brief Summary

The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are:

  1. 1.What impact does coronary artery disease have on the ability for a patient to tolerate VT?
  2. 2.Does treatment of coronary artery disease with stents improve the tolerability of VT?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Aug 2023Jun 2026

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

March 23, 2023

Last Update Submit

March 24, 2026

Conditions

Ventricular TachycardiaHeart FailureCoronary Artery DiseaseCoronary Microvascular DysfunctionCoronary Microvascular Disease

Keywords

Ventricular TachycardiaCoronary Artery DiseaseHeart FailureCoronary Microvascular DysfunctionCoronary Microvascular DiseasePercutaneous Coronary InterventionImplantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (4)

  • Change in coronary flow in participants with different levels of coronary microvascular function.

    At baseline and during simulated VT

  • Change in coronary flow in participants immediately before and after PCI

    At baseline and during simulated VT, immediately before PCI and after PCI

  • Change in blood pressure in participants with different levels of coronary microvascular function.

    At baseline and during simulated VT

  • Change in blood pressure in participants before and after PCI

    At baseline and during simulated VT, immediately before PCI and after PCI

Secondary Outcomes (2)

  • Change in coronary flow in participants with different levels of left ventricular function

    At baseline and during simulated VT

  • Change in blood pressure in participants with different levels of left ventricular function

    At baseline and during simulated VT

Study Arms (4)

Controls

10 patients with unobstructed coronary arteries, normal microvascular function and normal LV function.

Diagnostic Test: Pressure and flow measurement during simulated VT

Coronary artery disease

25 patients with severe, single-vessel coronary artery disease of the proximal LAD or proximal other dominant vessel awaiting PCI.

Diagnostic Test: Pressure and flow measurement during simulated VT

Microvascular dysfunction

15 patients with without severe disease in any coronary artery, impaired microvascular function and normal LV function.

Diagnostic Test: Pressure and flow measurement during simulated VT

Heart failure

20 patients with LV systolic dysfunction (LVEF\<40%).

Diagnostic Test: Pressure and flow measurement during simulated VT

Interventions

Pressure and flow measurement during simulated VTDIAGNOSTIC_TEST

Participants undergoing coronary angiography will have measurements of blood pressure, coronary pressure and coronary flow during simulated VT. VT will be simulated using pacing at a range of heart rates.

ControlsCoronary artery diseaseHeart failureMicrovascular dysfunction

Eligibility Criteria

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

Adults referred for coronary angiography or coronary angioplasty.

You may qualify if:

  • Able to give valid consent
  • Referred for coronary angiography or coronary angioplasty
  • Suitable for percutaneous physiological interrogation and PCI when clinically indicated

You may not qualify if:

  • Unable to give valid consent
  • Pregnant or breastfeeding women
  • Unstable coronary artery disease (acute coronary syndrome)
  • Severe multivessel coronary artery disease suitable for coronary artery bypass grafting
  • Severe heart valve disease
  • Severe (NYHA IV) heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College NHS Foundation Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularCoronary Artery DiseaseHeart FailureMicrovascular Angina

Interventions

Pressure

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina Pectoris

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Ricardo Petraco

    Senior Clinical Research Fellow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Bahl

CONTACT

+44 20 7594 1093r.bahl@imperial.ac.uk

Ricardo Petraco

CONTACT

+44 20 7594 1093r.petraco@imperial.ac.uk

Study Design

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

Study Record Dates

First Submitted

March 23, 2023

First Posted

May 3, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

June 2, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

GB(1)