Angina RefractoryNCT03516643
Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina
A study testing Extracorporeal Shockwave Myocardial Revascularization in people with Angina Refractory and Angina Pectoris, run by University of Turin, Italy.
Trial summary
This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Refractory, Angina Pectoris
- What is being tested?
- Extracorporeal Shockwave Myocardial Revascularization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2018
- 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
- history of coronary artery disease;
- refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon);
- stable maximal medical therapy for at least 6 weeks;
- stress-induced ischemia at baseline SPECT;
- left ventricular ejection fraction higher than 40%;
- age higher than 18 years.
Who cannot join
- myocardial infarction or unstable angina in the previous 3 months,
- acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis
- pregnancy
About this study
Official title: Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort
This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.
- Conditions
- Angina Refractory, Angina Pectoris
- Being tested
- Extracorporeal Shockwave Myocardial Revascularization
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave Myocardial RevascularizationOther
Also called ESMR
extracorporeal shockwave in ischemic area evaluated by SPECT
| Study group | Role | What they receive |
|---|---|---|
| Shockwave | Experimental | Extracorporeal Shockwave treatment on Ischemic Myocardium Receives: Other: Extracorporeal Shockwave Myocardial Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of myocardial perfusion
Reduction in stress-induced ischemia at SPECT
Measured: 6months after ESMR
Secondary outcomes (3)
Reduction of symptoms
Improvement of CCS class
Measured: 1, 6, 12 months
Reduction of symptoms
Improvement of NYHA class
Measured: 1, 6, 12 months
Reduction of symptoms
Reduction of oral nitrates need
Measured: 1, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startJan 2009
- Primary completionJan 2010
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina RefractoryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Alunni, University of Turin, Italy
- Investigators
- Gianluca Alunni, Principal investigator, Città della Salute e della Scienza of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516643
- Sponsor's protocol ID
- 01
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort
- ClinicalTrials.gov ID
- NCT03516643
- Acronym / sponsor ID
- 01
- Conditions
- Angina Refractory, Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 May 2018 (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.
This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shockwave | Experimental | Other: Extracorporeal Shockwave Myocardial RevascularizationExtracorporeal Shockwave treatment on Ischemic Myocardium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- history of coronary artery disease;
- refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon);
- stable maximal medical therapy for at least 6 weeks;
- stress-induced ischemia at baseline SPECT;
- left ventricular ejection fraction higher than 40%;
Key exclusion criteria (3 listed)
- myocardial infarction or unstable angina in the previous 3 months,
- acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis
- pregnancy
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 |
|---|---|---|
| Extracorporeal Shockwave Myocardial RevascularizationAlso: ESMRextracorporeal shockwave in ischemic area evaluated by SPECT | Other | Shockwave |
Primary outcome
Improvement of myocardial perfusion
Time frame: 6months after ESMR
Reduction in stress-induced ischemia at SPECT
3 secondary outcomes
Reduction of symptoms
Time frame: 1, 6, 12 months
Reduction of symptoms
Time frame: 1, 6, 12 months
Reduction of symptoms
Time frame: 1, 6, 12 months
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 4 May 2018.
- Individual participant dataSharing planned: No
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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.
Gianluca Alunni principal investigator
Città della Salute e della Scienza of Torino
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Myocardial Revascularization in people with Angina Refractory and Angina Pectoris, run by University of Turin, Italy.
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 6 inclusion and 3 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Improvement of myocardial perfusion (time frame: 6months after ESMR). 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 4 May 2018.