- Our primary objective is to analyze if MR perfusion imaging can guide therapy, improve patient safety and reduce costs. - The secondary objective is to determine the optimal therapy for patients with stable angina.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are a combined endpoint of time to adverse cardiac
events defined as: all-cause mortality, myocardial infarction/acute coronary
syndrome, hospitalization for unstable angina with negative biomarkers,
coronary artery bypass grafting and coronary angioplasty.
Secondary outcome
The secondary end points are quality of life (Canadian Cardiovascular Society
angina class at follow-up); the usage of antianginal drugs, cost-effectiveness
and the prognostic value of hs-cTNT.
Background summary
The number of percutaneous coronary interventions (PCI*s) is rising and more
hospitals wish to establish PCI-centers. However, PCI in patients with coronary
artery disease is often based on morphological aspects only. The optimal
therapy for patients with stable angina is under discussion: According to the
COURAGE-trial, PCI as an initial treatment for stable angina did not reduce the
risk of death or cardiovascular events. MR perfusion imaging has been shown to
non-invasively detect myocardial perfusion abnormalities in patients with
coronary artery disease and to correlate to invasive measurements of fractional
flow reserve. As the event rate in patients with normal MR perfusion results is
low, we hypothesize that:
- MR imaging predicts the prognosis in patients with stable angina and guides
therapy (medical treatment for minor / PCI for major ischemia),
- Triage with MR perfusion imaging can improve patient safety and reduce costs.
- Patients with major myocardial ischemia will benefit more from PCI than
patients with minor or no ischemia
Study objective
- Our primary objective is to analyze if MR perfusion imaging can guide
therapy, improve patient safety and reduce costs.
- The secondary objective is to determine the optimal therapy for patients with
stable angina.
Study design
This is a prospective, randomized controlled study. CT angiography or coronary
angiography will be performed to confirm the presence of significant coronary
artery disease (>=70% stenosis). Patients will then be randomly assigned into
two groups:
1) Randomization to looking at MR perfusion test results. MR perfusion imaging
has been shown to correlate to invasive measurements of fractional flow
reserve: a cutoff of 1.5 myocardial perfusion reserve (MPR) separates
hemodynamically relevant from nonrelevant stenosis.
a. Minor ischemia (defined by visual and semi-quantitative analysis) on MR
perfusion test: medical treatment.
b. Major ischemia (defined by visual and semi-quantitative analysis) on MR
perfusion test: PCI in addition to medical treatment.
2) Randomization to not looking at MR perfusion test results: medical treatment.
All patients will undergo adenosine stress MR perfusion imaging.
Clinical follow-up will be performed for 5 years with yearly outpatient clinic
visits and questionnaires.
Intervention
Patients with major ischemia in the *treatment with knowledge of MRI results*-
group will undergo PCI according to standard technique. The cardiologist will
insert a sheath into the femoral artery (or in some cases the brachial artery).
A guiding catheter is pushed through this sheath and placed at the mouth of the
coronary artery. Then, a small balloon on a guide wire is passed through the
catheter into the coronary artery. The balloon is inflated at the location of
the stenosis, which opens the blood vessel. In some cases the cardiologist will
opt to use a stent on the balloon. The stent will be pressed into the arterial
wall and left behind to ensure that the artery stays open.
Study burden and risks
Patients will undergo routine diagnostic work-up (i.e. physical examination,
blood studies, ECG, CT angiography or coronary angiography) and one adenosine
stress MR perfusion scan. Adenosine stress MR perfusion is an established
method to detect myocardial ischemia and is at least non-inferior to
SPECT-imaging. The use of adenosine infusion is safe and side effects are
transient and generally well tolerated. Serious side effects are relatively
rare, and they reverse with termination of adenosine infusion. Patients will
then be treated according to their randomization:
1) Treatment with knowledge of MR results
a. Medical treatment in case of minor ischemia (defined by visual and
semi-quantitative analysis).
b. PCI in addition to medical treatment in case of major ischemia (defined by
visual and semi-quantitative analysis).
2) Treatment without knowledge of MR results
a. Medical treatment for all patients randomized to this group
PCI will be performed in standard technique. All patients will receive clinical
follow-up for 5 years with yearly outpatient clinic visits and questionnaires.
P. Debyeplein 25
6229 HX Maastricht
NL
P. Debyeplein 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
All patients with stable angina pectoris and >=70% stenosis in at least one epicardial coronary artery (proximal or mid segment) can be included. Stable angina pectoris is defined as Canadian Cardiovascular Society [CCS] class I-III or medically stabilized class IV angina. Patients must be able to give informed consent.
Exclusion criteria
General:
- Age < 18 years.
- Pregnancy.
- Significant systemic hypertension (BP > 200/100mmHg) unresponsive to medical therapy.;Other cardiac pathology:
- Atrial fibrillation.
- Cardiogenic shock.
- Previous myocardial infarction, defined as: (UNL = upper normal limit)
a) New Q wave at any time.
b) Spontaneous, total CK/CK-MB >= 1.5 x UNL or troponin >= 2 x UNL.
- Congestive heart failure NYHA class >=III.
- Previous CABG or PCI.
- Unstable angina pectoris (persistent CCS class IV despite medical treatment).
- Left main (>= 50%) or 3 vessel disease or markedly positive treadmill test during stage 1 of the Bruce protocol.
- Ejection fraction < 30 %
- Concomitant valvular disease likely to require surgery or affect prognosis during follow up.
- Congenital or primary cardiac muscle disease likely to affect prognosis during follow-up.
- Resuscitated out-of-hospital sudden death or symptomatic sustained or non-sustained ventricular tachycardia.
Contraindications to MR imaging:
- Noncompatible metallic implant (vascular clip, neurostimulator, cochlear implant).
- Pacemaker or ICD.
- Claustrophobia.
- Body weight >130 kg. ;Contraindication to MRI contrastagent (Gadolinium):
- Renal failure (estimated GFR <= 30 mL/min) or chronic kidney disease stage 4 & 5. ;Contraindication to adenosine side effects:
- AV-block (2nd or 3rd degree).
- Severe asthma.
- COPD Gold IV.;To exclude patients with chest pain from non-cardiac origin, CT-angiography or coronary angiography will be performed to confirm the presence of significant coronary artery disease (>=70% stenosis).
Design
Recruitment
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 | NL30607.068.09 |