VT flow: Coronary Flow During Rapid Heart Rates

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841199
Collaborator
(none)
70
1
32.1
2.2

Study Details

Study Description

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. What impact does coronary artery disease have on the ability for a patient to tolerate VT?

  2. Does treatment of coronary artery disease with stents improve the tolerability of VT?

Participants who are undergoing a clinically indicated coronary angiogram or coronary angioplasty procedure will have measurements of blood pressure, coronary pressure and coronary flow made during pacing at a range of heart rates.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pressure and flow measurement during simulated VT

Detailed Description

Ventricular tachycardia (VT) is a common and life-threatening arrhythmia that occurs in people with heart problems. Some patients who develop this arrhythmia remain very stable with very little symptoms while others become unstable with low blood pressure or even sudden death. It is not known why some people tolerate the arrhythmia well and others do not.

If VT is not tolerated then current practice is to offer an implantable cardioverter defibrillator (ICD) which can deliver a shock to the heart if dangerous heart rhythms are detected. While shocks can be life-saving, they are also harmful, including causing psychological distress. ICDs also frequently deliver shocks when they are not needed.

If research could identify which factors predispose a person to be stable or unstable in VT, this would allow doctors to help them in a range of ways. One way would be to treat patients to improve the tolerance of VT, so avoiding the need for an ICD. Another would be to assess the the risk of instability and so allow a patient-centred decision on whether an ICD is needed.

In this study the investigators plan to recruit patients who are referred for a coronary angiogram. During the angiogram, the investigators will stimulate the heart at a range of fast heart rates and measure their blood pressure and flow in their coronary arteries. In patients who undergo stenting for a coronary stenosis, the investigators will also make these measurements after stenting so they can see if there is any difference. By recruiting a range of different cardiology patients, the investigators will be able to assess which factors contribute to stability during VT.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Coronary Epicardial and Microcirculatory Determinants of Ventricular Tachycardia Tolerability
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Feb 2, 2026
Anticipated Study Completion Date :
Feb 2, 2026

Arms and Interventions

Arm Intervention/Treatment
Controls

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

Diagnostic Test: Pressure and flow measurement during simulated VT
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.

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
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.

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
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.

Heart failure

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

Diagnostic Test: Pressure and flow measurement during simulated VT
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.

Outcome Measures

Primary Outcome Measures

  1. Change in coronary flow in participants with different levels of coronary microvascular function. [At baseline and during simulated VT]

  2. Change in coronary flow in participants immediately before and after PCI [At baseline and during simulated VT, immediately before PCI and after PCI]

  3. Change in blood pressure in participants with different levels of coronary microvascular function. [At baseline and during simulated VT]

  4. Change in blood pressure in participants before and after PCI [At baseline and during simulated VT, immediately before PCI and after PCI]

Secondary Outcome Measures

  1. Change in coronary flow in participants with different levels of left ventricular function [At baseline and during simulated VT]

  2. Change in blood pressure in participants with different levels of left ventricular function [At baseline and during simulated VT]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Able to give valid consent

  • Referred for coronary angiography or coronary angioplasty

  • Suitable for percutaneous physiological interrogation and PCI when clinically indicated

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College NHS Foundation Trust London United Kingdom W12 0HS

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: Ricardo Petraco, Senior Clinical Research Fellow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05841199
Other Study ID Numbers:
  • 22HH7955
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023