Change in Exercise Capacity as Measured by Peak Oxygen Uptake After CTO PCI (EXERTION)

February 18, 2022 updated by: Khaldoon Alaswad, MD, Henry Ford Health System

Evaluation of Exercise Capacity as Measured by Peak Oxygen Uptake, Before and After Percutaneous Revascularization of Chronic Total Occlusion

The purpose of this project is to objectively assess the change (improvement) in exercise capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic total occlusion (CTO)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PURPOSE: The purpose of this project is to objectively assess the change (improvement) in exercise capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic total occlusion (CTO)

AIMS: The primary aim of this study is to identify any improvement in exercise capacity as measured by peak oxygen uptake (VO2) and quality of life survey, for both symptomatic and asymptomatic patients (each group will be analyzed separately). 2) The secondary aim is to identify any cardiopulmonary exercise testing (CPX) predictors of exercise improvement that may then be used for selecting optimal CTO PCI candidates

RATIONALE: Chronic Total Occlusion (CTO) of a coronary vessel is defined as 100% occlusion of a coronary artery for more than 3 months. The prevalence of coronary CTO ranges from 18-34% in patients with coronary artery disease. Because of new developments in the techniques and the available technology Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI) has been performed more frequently. The effects of successful CTO PCI on the objective findings of CPX has never been studied before. Registry and retrospective small studies have shown that successful CTO PCI decreases angina and ischemic burden, improves left ventricular function, reduces the risk of arrhythmias, increases tolerance to acute coronary syndromes, decreases the need for coronary artery by pass surgery, and improves the patient quality of life. The American College of Cardiology - American Heart Association PCI Guidelines give this procedure a Class IIa recommendation in specialized centers with expertise in CTO PCI. The ultimate goal of coronary intervention is not only improved survival and surrogate markers like left ventricular function, but improvement of quality of life. While angina is a subjective marker of quality of life, the patient's experience of angina will depend upon the degree to which the patient engages in exertion. Many patients subconsciously or consciously adjust their routine activities and exercise level to be below the threshold at which they experience angina, shortness of breath, or fatigue. The investigators therefore aim to quantify the degree to which there is any change in exercise capacity as measured by peak oxygen uptake (VO2) and a quality of life questionnaire. This information may help future patients and physicians provide prognostic information about the potential benefits of CTO PCI. Furthermore, as a secondary aim, the investigators will evaluate any CPX predictors of post PCI improvement in exercise capacity. This information may help establish algorithms for those patients who will most benefit from CTO PCI. The investigators aim to 1- objectively quantify the negative effects of coronary CTO on the CPX parameters (peak oxygen uptake), 2- demonstrate the effects of successful CTO PCI on CPX parameters especially in asymptomatic patients 3- determine the patient and procedural findings that determine improvement in CPX parameters.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who present for evalaution of CTO-PCI (male and female, age >18 years old) will be asked to participate in the study. Patients unable to exercise for any reason will be excluded.

Description

Inclusion Criteria:

  • Patients who present for percutaneous intervention of chronic total occlusion who are able and willing to perform treadmill cardiopulmonary stress testing before and after the intervention

Exclusion Criteria:

  • Patients who present for percutaneous intervention of chronic total occlusion who are unable or unwilling to perform treadmill cardiopulmonary stress testing before and after the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic
Patients with known chronic total occlusion who are undergoing percutaneous coronary intervention wtih balloon angioplasty and coronary stent placement who are currently asymptomatic (without any chest pain or anginal equivalent) but have decreased exercise capacity or are easily fatigued. Patients will also be on dual antiplatelet therapy with aspirin and a second agent such as clopidogrel.
Procedure: Percutaneous Coronary Intervention
As clinically indicated, patients will have a percutaneous balloon angioplasty and stent deployment of a chronic total occlusion (i.e., an artery that has a 100% blockage for several months).
Device: Coronary stent
As clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty
Drug: Clopidogrel
As clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel.
Other Names:
  • Plavix
Symptomatic
Patients with known chronic total occlusion who are undergoing percutaneous coronary intervention with balloon angioplasty and coronary stent placement who are currently symptomatic with chest pain or anginal equivalent.. Patients will also be on dual antiplatelet therapy with aspirin and a second agent such as clopidogrel.
Procedure: Percutaneous Coronary Intervention
As clinically indicated, patients will have a percutaneous balloon angioplasty and stent deployment of a chronic total occlusion (i.e., an artery that has a 100% blockage for several months).
Device: Coronary stent
As clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty
Drug: Clopidogrel
As clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel.
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Exercise Capacity
Time Frame: Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention
Evaluate change in exercise capacity as determined by peak VO2 by comparing pre and post percutaneous intervention cardiopulmonary exercise test results
Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of Change in Exercise Capacity
Time Frame: Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention
Analyze cardiopulmonary stress test data for any variables that are predictive of improvement in exercise capacity after percutaneous intervention of chronic total occlusion
Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Khaldoon Alaswad, MD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2015

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9608 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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