CADPhase 2/3NCT00176358
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
A Phase 2/3 study testing PTCA and Stent Implantation and Exercise Training in people with CAD and Stable Angina Pectoris, run by University of Leipzig at 1 site in Germany.
Trial summary
The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CAD, Stable Angina Pectoris
- What is being tested?
- PTCA and Stent Implantation and Exercise Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA).
- Stable coronary artery disease
- Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society [CCS]) with documented myocardial ischemia
- Angina pectoris threshold > 50 Watt (cycle ergometry)
- Permanent residence should be within 25 km of training facility.
Who cannot join
- < 18 or > 70 years of age
- Patient currently participating in an exercise training program
- Unstable angina pectoris or myocardial infarction during the last 2 weeks
- Symptoms of CCS class IV
- Exercise limitations due to clinical conditions not related to CAD
- Left ventricular ejection fraction (LVEF) of < 40%
Show all 12Show fewer
- Ventricular arrhythmia (Lown Ivb)
- Hemodynamically significant valvular heart disease
- Previous cardiac surgery
- PTCA performed during the last 12 months
- Any major non-cardiac condition that would adversely affect survival during the duration of the study
- Reduced compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig - Heart Center
Leipzig, 04289
Sven Möbius-Winkler, MD, 00493418650
Sven Möbius-Winkler, MD
About this study
The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).
- Conditions
- CAD, Stable Angina Pectoris
- Being tested
- PTCA and Stent Implantation, Exercise Training
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCA and Stent ImplantationDevice
Exercise TrainingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Rainer Hambrecht, Prof., Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176358
- Sponsor's protocol ID
- 139/2001
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00176358
- Acronym / sponsor ID
- 139/2001
- Conditions
- CAD, Stable Angina Pectoris
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- First posted
- 15 Sep 2005 (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 study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA).
- Stable coronary artery disease
- Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society [CCS]) with documented myocardial ischemia
- Angina pectoris threshold > 50 Watt (cycle ergometry)
- Permanent residence should be within 25 km of training facility.
Key exclusion criteria (12 listed)
- < 18 or > 70 years of age
- Patient currently participating in an exercise training program
- Unstable angina pectoris or myocardial infarction during the last 2 weeks
- Symptoms of CCS class IV
- Exercise limitations due to clinical conditions not related to CAD
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 |
|---|---|---|
| PTCA and Stent Implantation | Device | – |
| Exercise Training | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
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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.
Rainer Hambrecht, Prof. principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PTCA and Stent Implantation and Exercise Training in people with CAD and Stable Angina Pectoris, run by University of Leipzig at 1 site in Germany.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Sep 2007. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Hambrecht, Prof. (00493418651426, rhambrecht@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 10 Sep 2007.