Problem definition and objectivesThe microcirculation can only be measured by coronary blood flow parameters during catheterization. Patients with MVD will be offered an unique first in man non-invasive therapy namely: external low intensity shock…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
The primary endpoint at 6 months is:
- Improvement of the index of microvascular resistance (IMR)
Secondary outcome
The secondary outcomes at 6 months are:
- Improvement in invasive parameter of MVD measured as coronary flow reserve
(CFR)
- Self (patient)-assessed angina score and quality of life, assessed with the
Seattle Angina and SF-36 Questionnaire
- Improvement of exercise capacity measured in metabolic equivalents (MET)
scores during bicycle test
- Use of short-acting nitrates
Background summary
Angina is generally ascribed to obstructive coronary artery disease (CAD, but
40% does not have CAD on catheterization. For a long time these patients were
not recognized in their symptoms with a predominance in female patients.
However, there is much more to coronary circulation beyond epicardial arteries
namely the microvasculature which is a complex and structured system of small
vessels (<400µm) which adapt their function in order to sustain the
myocardium*s physiological needs. The clinical importance of this vascular
compartment has become apparent in light of the significant proportion of
patients presenting signs and symptoms of myocardial ischemia, despite the
absence of epicardial disease. Patients with coronary microvascular dysfunction
(MVD) have increased cardiovascular risk, high morbidity and impaired quality
of life. Therefore they are a source of considerable health resource
utilization as no interventional therapies exist. The only treatment option is
an extensive mix of medication which is often inadequate and hampered by its
side-effects.
Study objective
Problem definition and objectives
The microcirculation can only be measured by coronary blood flow parameters
during catheterization. Patients with MVD will be offered an unique first in
man non-invasive therapy namely: external low intensity shock wave (LiSW). This
therapy has been shown to be effective in small trials, which have been done in
patients with refractory angina and severe coronary artery disease beyond
repair. LiSW therapy improves blood flow by promoting neovascularization and
ameliorating inflammatory processes. We will test whether LiSW improves
microvascular dysfunction by measuring coronary blood flow parameters before
and after therapy and if it improves angina status.
Study design
Patients with mivrovascular dysfunciton are identified during their initital
coronary angiogram.
After informed consent they will receive the Low intensity Shock Wave
treatment. The protocol consist of 3 treatment er week at baseline, 1 months
and 2 months (in total 9 sessions). Per session 3-10 areas are treated with the
Cardiospec shockwave. 4 months thereafter a new coronary angigoram will be
repeated to asses if improvement of microvascular dysfunction has occured.
Furthermore, patients will undergo a bicycle test and a health care
questionnaire at baseline en follow-up.
Study burden and risks
No adverse events are to be expected from the CE marked medical product namely
low-intensity shockwave therapy which has been studied in >1000 patients. After
shock wave therapy patients will receive another coronary angiogram with
invasive measurements for microvascular function. The first investigation was
performed for clinical needs, the second one during follow-up for research
purposes. The potential risks are the same, namely rhythm disorder, chest pain,
allergic reaction to the contrast fluid, hematoma or infection. There are
several potential severe complications such as wire perforation, injury to
heart or brain by thrombo- or cholesterol embolism which is estimated to be
less than 1 in 1000 patients
Henri dunantstraat 5
Heerlen 6419 PC
NL
Henri dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
1. Stable Angina, defined as: - Angina with exercise or rest - Exertional
dyspnea 2. Age >=18 years 3. Angina without flow limiting CAD defined as
epicardial stenosis <50% or FFR >0.80 4. presence of MVD defined as IMR> 30
Exclusion criteria
* noncardiac origin of chest pain, such as gastrointestinal or musculoskeletal
* Recent (<3 months) myocardial infarction * Severe aortic valve stenosis/
elevated LVEDP * History of coronary artery bypass graft * Known cardiomyopathy
or myocarditis * Bad acoustic windows in supine position * LV thrombus * ICD/
pacemaker * Extra-cardiac illness that is expected to limit survival to less
than 1 years * Active participation in another trial * Unable to give informed
consent or potential for noncompliance with the study protocol in the judgment
of the investigator * Pregnant at the time of screening or unwilling to use
effective birth control measures
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84092.096.23 |