Coronary Artery DiseaseNCT03221712
The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries
An observational study of Coronary Artery Disease and Total Occlusion of Coronary Artery, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Total Occlusion of Coronary Artery
- What is being tested?
- cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2017to 1 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
Who may be able to join
- Age 19 and more
- Chronic total occlusion of coronary artery disease
- Cardiac rehabilitation
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
- Being tested
- cardiac rehabilitation
- Keywords
- cardiopulmonary exercise test, chronic total occlusion, cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationBehavioural
cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 5 year
Myocardial infarction
Measured: 5 year
Repeat revascularization
Measured: 5 year
Secondary outcomes (4)
Maximum rate of oxygen consumption
maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill.
Measured: 5 year
Respiratory exchange ratio
Measured: 5 year
Maximal heart rate
Measured: 5 year
Physical activity_METs
Physical activity is measured in metabolic equivalents (METs), which are multiples of the resting rate of O2 consumption.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start31 Aug 2017
- Primary completion31 Aug 2017
- Study completion1 Dec 2017
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
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221712
- Sponsor's protocol ID
- AMCCV retrospective
- Status last verified
- Dec 2017
- First submitted
- 16 Jul 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries
- ClinicalTrials.gov ID
- NCT03221712
- Acronym / sponsor ID
- AMCCV retrospective
- Keywords
- cardiopulmonary exercise test, chronic total occlusion, cardiac rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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 aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
Key inclusion criteria (3 listed)
- Age 19 and more
- Chronic total occlusion of coronary artery disease
- Cardiac rehabilitation
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| cardiac rehabilitationcardiac rehabilitation in patients with chronic total occlusion of the coronary arteries. | Behavioural | – |
Primary outcome
Death
Time frame: 5 year
Myocardial infarction
Time frame: 5 year
Repeat revascularization
Time frame: 5 year
4 secondary outcomes
Maximum rate of oxygen consumption
Time frame: 5 year
Respiratory exchange ratio
Time frame: 5 year
Maximal heart rate
Time frame: 5 year
Physical activity_METs
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Total Occlusion of Coronary Artery, run by Seung-Jung Park at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 19 Dec 2017. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: 5 year). The study lists 3 primary outcomes in all. 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 19 Dec 2017.