AnginaSWAAMNCT01361659
Shockwave Treatment for Advanced Angina in Maastricht
A study testing shockwave treatment in people with Angina, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina
- What is being tested?
- shockwave treatment
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Dec 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
- Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
- No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
- Patient's conditions stable for at least 3 months
- Life expectancy of > 12 months.
Who cannot join
- Unstable angina pectoris
- Haemodynamically significant valvular heart disease
- Myocardial infarction <3 month prior randomization
- Evidence of intracardiac thrombus
- Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
- Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
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- Patients who are unwilling or unable to cooperate with the study procedure.
- Age < 18 years
- Cardiac or pulmonary malignancy
- No informed consent
- Known depression
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
Jindra Vainer, MD, +31433875106, J.Vainer@mumc.nl
H. Crijns, Prof Dr.
About this study
Official title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
- Conditions
- Angina
- Being tested
- shockwave treatment
- Keywords
- anginal complaints, Lithotripsy, no option patients
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave treatmentProcedure or surgery
9 treatments in 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of exercise tolerance
Modified Bruce protocol, changes compared to the baseline
Measured: after 6 months
Secondary outcomes (3)
Improvement of myocardial perfusion
myocardial perfusion scintigraphy changes compared to the baseline
Measured: 6 months
Number of Patients with Adverse Events as a Measure of Safety
Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.
Measured: 6 months
Improvement of quality of life
Number of anginal attacks/week, use of nitrates/week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startMay 2007
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medispec ltd.
- Investigators
- H. Crijns, Prof Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361659
- Sponsor's protocol ID
- 07-2-008
- Acronym
- SWAAM
- Status last verified
- Jul 2011
- First submitted
- 12 Apr 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
- ClinicalTrials.gov ID
- NCT01361659
- Acronym / sponsor ID
- SWAAM / 07-2-008
- Conditions
- Angina
- Keywords
- anginal complaints, Lithotripsy, no option patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Medispec ltd.
- Study start
- May 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 May 2011 (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.
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
- Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
- No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
- Patient's conditions stable for at least 3 months
- Life expectancy of > 12 months.
Key exclusion criteria (11 listed)
- Unstable angina pectoris
- Haemodynamically significant valvular heart disease
- Myocardial infarction <3 month prior randomization
- Evidence of intracardiac thrombus
- Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
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 |
|---|---|---|
| shockwave treatment9 treatments in 3 months | Procedure or surgery | – |
Primary outcome
Improvement of exercise tolerance
Time frame: after 6 months
Modified Bruce protocol, changes compared to the baseline
3 secondary outcomes
Improvement of myocardial perfusion
Time frame: 6 months
Number of Patients with Adverse Events as a Measure of Safety
Time frame: 6 months
Improvement of quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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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.
H. Crijns, Prof Dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shockwave treatment in people with Angina, run by Maastricht University Medical Center at 1 site in Netherlands.
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 11 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 12 Jul 2011. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jindra Vainer, MD (+31433875106, J.Vainer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of exercise tolerance (time frame: after 6 months). 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 12 Jul 2011.