Exercise in Patients With a Total Coronary Occlusion

NCT03993522 | Terminated DMC

• 1 other identifier: 18/SC/0461
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A coronary chronic total occlusion refers to the long term complete blockage of a blood vessel supplying the heart. Exercise is beneficial for patients with heart problems, including people with narrowed blood vessels. However, exercise has not previously been tested in patients with a completely blocked blood vessel. Therefore, the aim of this study is to evaluate exercise testing in participants with a coronary chronic total occlusion, and to see if the physiological changes that occur are reproducible when participants are re-tested. Secondly, the study will see if sustained exercise is safe in this population. Participants will make 3 visits to our Laboratory. During the first two visits participants will complete symptom limited exercise tests using a stationary bike for approximately 8-12 minutes. The bikes' resistance will gradually increase until participants choose to stop or the researcher ends the test. Participants will wear a mask that collects exhaled breath for testing, and will be connected to an electrocardiogram (heart trace monitor), and blood pressure cuff for monitoring throughout the test. During visits one and three patients will also have blood taken pre and post exercise. Researchers will analyse how the amount of oxygen consumed with increasing exercise relates to the participants' heart rate. A plateau in these measures would indicate a change in the heart's blood supply resulting in reduced function. The participants' third visit will involve cycling under the same conditions as previous visits. However, during this test participants will be asked to cycle continuously for 20 minutes at a resistance set by the researchers. This level of resistance is determined from the results of the first test, as the point at which changes in blood flow and heart function occurred. In the last five minutes of the test patients will have an echocardiogram (heart scan), to look at the heart function.

Conditions

Coronary Occlusion

Keywords

Chronic Total Occlusion (CTO)

Outcome Measures

Primary Outcomes (2)

• intra-patient variability in O2/HR and, ΔO2/ΔWR inflections

  • To assess the intra-patient variability in the occurrence of the O2/HR and, ΔO2/ΔWR inflection in patients with a CTO during an individualised maximal CPET.

  3 weeks

• Verification of myocardial dysfunction during inflections via stress echocardiography

  • To verify that the O2/HR and, ΔO2/ΔWR inflection indicates the onset of exercise induced myocardial dysfunction by visual confirmation of its occurrence using stress-echocardiography

  6 weeks

Secondary Outcomes (1)

• Record any signs of myocardial ischemia, along with adverse and serious adverse events during or following sustained exercise at this intensity

  6 weeks

Study Arms (1)

CTO Exerciser

EXPERIMENTAL

2x Symptom limited cardiopulmonary exercise tests 1x Sub-maximal cardiopulmonary exercise test (20 minutes)

Other: Symptom limited cardiopulmonary exercise test & Sub-maximal cardiopulmonary exercise test

Interventions

Symptom limited cardiopulmonary exercise test & Sub-maximal cardiopulmonary exercise test OTHER

Exercise tests on cycle ergometer for the purpose of collecting expired breath gasses

Also known as: CPET

CTO Exerciser

Eligibility Criteria

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

You may qualify if:

• Single vessel disease with a chronic total occlusion of the right coronary artery, left anterior descending artery, or left circumflex artery, as identified on coronary angiography performed within the preceding 24 months.
• Willingness to undertake maximal cardiopulmonary exercise test
• Resting systolic blood pressure \<180mmHg
• Resting Diastolic blood pressure \<100mmHg
• Aged \>18yrs
• Normal resting left ventricular function
• Able to provide written informed consent

You may not qualify if:

• Significant proximal left main stem stenosis.
• Multi-vessel disease (defined as a diameter stenosis of \>50% in another major epicardial coronary vessel)
• Absence of exercise-induced ischaemia evidenced by O2/HR or, ΔVO2/ ΔWR inflection at visit 1 and 2
• O2/HR inflection or, ΔVO2/ ΔWR inflection at a respiratory exchange ratio \>1.05
• Change in cardiac medications within previous two weeks
• Unstable angina
• Myocardial infarction within the preceding 6 weeks
• Canadian classification system for angina class IV
• Chronic heart failure
• Significant valvular pathology
• Resting ejection fraction \<40%
• Severe orthopaedic limitations
• Past history of Complex arrhythmias
• Atrial fibrillation
• Severe COPD

Sponsors & Collaborators

• University of Hull: lead
• Sheffield Hallam University: collaborator

Study Sites (1)

Daisy building Castle Hill Hospital

Hull, Cottingham, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Occlusion

Interventions

Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Angela Hoye, MB, ChB, PhD

  Hull York Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: June 20, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)