1) Assessment of the prognostic value of epicardial (FFR, CFR, REF-CFR and HSR) and microvascular (microvascular resistance; MR) parameters in patients with ACS and MVD. 2) Determination, quantification and development of epicardial and…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of cardiac death, acute myocardial infarction, recurrent
revascularization guided by objective evidence of myocardial ischemia at 12
months.
Secondary outcome
A composite of all-cause death, myocardial infarction, stroke, severe vascular
events, recurrent revascularization guided by objective evidence of myocardial
ischemia at 12 months.
Background summary
Multivessel coronary artery disease (MVD) occurs in around half of patients
presenting with acute myocardial infarction. At present, management is based on
treatment of the culprit coronary lesion only by primary percutaneous coronary
intervention (PCI) in the acute setting. The remaining lesion(s) will be
treated in a following procedure weeks or months later based on the first
angiogram, based on residual ischemia or based on residual complaints. Early
post AMI stress testing, such as myocardial perfusion scintigraphy, may be
inconclusive due to a reduced perfusion caused by an altered microvascular
resistance in infarct related and remote regions. Moreover, there is limited
data on the microcirculatory function in acute myocardial infarction (AMI) and
there are no data regarding the role of the microcirculation on the effects of
functional coronary lesion severity in these acutely ill patients. The
development of guidewires equipped with miniaturized pressure- or flow
velocity-sensors has led to the introduction of hemodynamic measurements in the
diseased coronary vessel and allow examination of the coronary (micro-)
circulation in significantly ill patients. In the line of research outlined in
this proposal we shall explore the diagnostic and prognostic value of invasive
parameters of myocardial ischemia; i.e. fractional flow reserve (FFR), coronary
flow reserve (CFR) and hyperemic stenosis resistance (HSR) in patients with AMI
and multivessel coronary artery disease. Moreover, the role of the
microcirculation (microvascular resistance; MR) on FFR, CFR, reference CFR
(REF-CFR) and HSR values will be studied.
Study objective
1) Assessment of the prognostic value of epicardial (FFR, CFR, REF-CFR and HSR)
and microvascular (microvascular resistance; MR) parameters in patients with
ACS and MVD.
2) Determination, quantification and development of epicardial and
microvascular disease parameters for ischemia in patients in with AMI and MVD.
3) Evaluation of the relation of biochemical markers and intracoronary
physiological and anatomical changes.
4) Evaluation of a cost effectiveness strategy in patients with AMI and MVD.
Study design
PCI will be performed during the first admission with a first AMI. After PCI of
the infarct related artery intracoronary pressure and flow will be assessed in
the treated vessel, the vessel with the residual coronary lesion(s) of interest
and the angiographic normal reference vessel (if present). Before hospital
discharge echocardiography will be performed and patients will undergo a
bycicle stress test. Patients who have a positive result of the stress test
will undergo a second cardiac catheterisation during which intracoronary
pressure and flow will be assessed as during primary PCI. In the case of both
FFR and CFR resembling myocardial ischemia, PCI of the lesion of interest will
be performed; in all other cases PCI will be deferred. Clinical follow up will
be performed on an outpatient basis at 2, 4, 12, 24 weeks and 1 year after
primary PCI. At these timepoints a venous bloodsample will be taken to
determine standard cardiac markers as troponin, CK-MB, NT-pro BNP and hsCRP
levels and a quality of life questionnaire will filled out. PCI of the
ischemia related coronary lesion will be performed when clinically indicated
(according to the Guidelines). Echocardiography will be performed before
discharge and after 24 weeks to assess cardiac function and abnormalities.
Intervention
In case of a postive exercise test, PCI of the laesion of interest will only be
performed when both CFR and FFR are indicative for ischemia.
Study burden and risks
In this study patients wil only undergo another cardiac catheterization when
this is clinically indicated regarding international guidelines.The risk
associated with intracoronary hemodynamic measurements is small in the hands of
an experienced operator. Sensor-equipped guide wires are approved for this
purpose (FDA and CE) and have been used as an adjunctive diagnostic tool at our
and other institutions for many years. The burden in this study is mainly due
to the more frequent clinical follow-up and the venous bloodsamples taken at
these timepoints.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with a second and/or third coronary lesion in the presence of a successfully treated acute coronary occlusion of another coronary vessel are amendable for inclusion.
Exclusion criteria
- Age under 18 and above 80 yrs.
- Cardiogenic shock
- Anatomical or anticipated problems for complete percutaneous coronary revascularization i.e. diffuse disease, chronic total occlusion.
- Prior or indication for coronary artery bypass grafting (CABG)
- Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis)
- Renal impairment (e.g. serum creatinine level of more than 130 *mol/L)
-Unable to exercise
-Ventricular arrhythmias, i.e. sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), more than 48 hours after primary PCI
-Severe valvular heart disease requiring cardiac surgery within twelve months
-Serious known concomitant disease with a life expectancy of less than one year
-Factors making follow-up difficult (e.g. not fixed home or address, psychological instability, drugs or alcohol addiction, etc.).
-Current participation in another trial.
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 | NL32391.018.10 |