Coronary Artery DiseaseEXERTIONNCT02499666
Change in Exercise Capacity as Measured by Peak Oxygen Uptake After CTO PCI
An observational study of Coronary Artery Disease and Angina Pectoris, run by Henry Ford Health System at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Percutaneous Coronary Intervention, Coronary stent and Clopidogrel
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2015to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Percutaneous Coronary Intervention, Coronary stent, Clopidogrel
- Keywords
- Exercise Capacity, Chronic Total Occlusion
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
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).
Coronary stentDevice
As clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty
ClopidogrelDrug
Also called Plavix
As clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous Coronary Intervention; Device: Coronary stent; Drug: Clopidogrel | |
| 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. Receives: Procedure: Percutaneous Coronary Intervention; Device: Coronary stent; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity
Evaluate change in exercise capacity as determined by peak VO2 by comparing pre and post percutaneous intervention cardiopulmonary exercise test results
Measured: 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 outcomes (1)
Predictors of Change in Exercise Capacity
Analyze cardiopulmonary stress test data for any variables that are predictive of improvement in exercise capacity after percutaneous intervention of chronic total occlusion
Measured: Patients will be followed up until their second cardiopulmonary exercise test, which will usually be scheduled 2-12 weeks after their percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start29 Jun 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Why it stopped: difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaldoon Alaswad, MD, Henry Ford Health System
- Investigators
- Khaldoon Alaswad, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499666
- Sponsor's protocol ID
- 9608
- Acronym
- EXERTION
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2015
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Exercise Capacity as Measured by Peak Oxygen Uptake, Before and After Percutaneous Revascularization of Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT02499666
- Acronym / sponsor ID
- EXERTION / 9608
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Exercise Capacity, Chronic Total Occlusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty recruiting patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic | – | Procedure: Percutaneous Coronary Intervention, Device: Coronary stent, Drug: ClopidogrelPatients 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. |
| Symptomatic | – | Procedure: Percutaneous Coronary Intervention, Device: Coronary stent, Drug: ClopidogrelPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionAs 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). | Procedure or surgery | Asymptomatic, Symptomatic |
| Coronary stentAs clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty | Device | Asymptomatic, Symptomatic |
| ClopidogrelAlso: PlavixAs clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel. | Drug | Asymptomatic, Symptomatic |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaldoon Alaswad, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.