To assess the rate of major adverse cardiac and cerebrovascular events (MACCE) between patients with and without coronary microvascular disease (CMD) based on Microvascular Resistance Reserve (MRR) at 1 year follow-up.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be the rate of major adverse cardiac and cerebrovascular
events at one year (MACCE - defined as cardiovascular death, myocardial
infarction, revascularization, angina and heart failure-related
hospitalizations, and stroke) between patients with and without CMD based on
MRR at 1 year follow-up.
Secondary outcome
Main Secondary endpoints:
1. Relationship between MACCE*s and each thermodilution derived metrics of
microvascular function (i.e., absolute hyperemic flow, absolute hyperemic
resistance, IMR and CFR).
2. Relationship between the presence and severity of angina, assessed by SAQ-
19, and each individual thermodilution-derived metrics of microvascular
function (i.e., absolute hyperemic flow, absolute hyperemic resistance, IMR and
CFR).
3. Relationship between the presence and severity of angina, assessed by the
Euro-CRAFT app, and each individual thermodilution-derived metrics of
microvascular function (i.e., absolute hyperemic flow, absolute hyperemic
resistance, IMR and CFR).
4. Safety of continuous and bolus thermodilution measurements, as assessed by
adverse event registration.
5. To determine cut-off values of thermodilution-derived indices.
6. To assess the prevalence of CMD based on MRR in patients with angina and
non-obstructive coronary artery disease (NOCAD).
Background summary
The arterial coronary circulation can be subdivided into two compartments: the
epicardial arteries and the microcirculation.
The microcirculation consists of arteries smaller than 500 micrometers and by
the capillary network. Its main function is to match blood flow to the needs of
the cardiac contractile apparatus. Accordingly, the function of the
microvasculature is primarily characterized by the microvascular
resistance, an index that is difficult to assess.
In a sizable proportion of patients with chest pain, no significant epicardial
narrowing can be seen at coronary angiography, even in case of typical anginal
complaints. This condition is defined as ischemia with no obstructive coronary
arteries (INOCA)(3-6) and often related to
microcirculatory dysfunction. In addition, in patients with acute coronary
syndromes, normal or near normal coronary angiograms may be found. Such
condition is known as myocardial infarction with no obstructive coronary
arteries (MINOCA).
We have introduced and validated a new invasive method to measure absolute
coronary flow (in mL/min) and absolute microvascular resistance (in Woods
Units, WU). The method is based on the continuous thermodilution principle.
Saline at room temperature is slowly but steadily infused
in the proximal part of the artery. The accuracy of thermodilution-derived flow
measurements has been validated against 15H2O-PET flow measurements.
A necessary prerequisite for clinical application of absolute coronary flow
(Q), microvascular resistance (Rµ) and of MRR is to establish some basic
characteristics of this new indices, to investigate feasibility and safety when
obtained on a broader scale by continuous thermodilution, to compare its value
to other existing metrics, and to correlate MRR to clinical outcome data.
Study objective
To assess the rate of major adverse cardiac and cerebrovascular events (MACCE)
between patients with and without coronary microvascular disease (CMD) based on
Microvascular Resistance Reserve (MRR) at 1 year follow-up.
Study design
The Euro-CRAFT Registry is an investigator-initiated, prospective,
multicentric, international registry of patients undergoing functional
assessment of the coronary microcirculation using the continuous thermodilution
technique.
Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 -
SAQ19, Euro-CRAFT smartphone app) will be obtained at baseline, at 6 months,
and 1-year follow-up.
Clinical follow-up will be performed at 1 year (optionally until 5 years).
Study burden and risks
In-hospital follow-up during baseline test: The occurrence of any complication
or adverse events should be reported. Hospital discharge will be done following
local practices.
Subsequent clinical follow-up will take place after 1 year and, optional yearly
till 5 years. SAQ-19 will be assessed at baseline, 6 months and 1 year
follow-up. Clinical follow-up and collection of questionnaires can be performed
either by in-hospital
visit or by phone.
Anticipated benefits for the patient
This prospective study doesn*t interfere with the normal diagnostic and
therapeutic process. The systematic assessment of the continuous thermodilution
curves may lead to a definitive diagnosis and guide treatment strategy. There
are no other anticipated benefits regarding the medical
treatment or treatment strategy before, during or after the study as there is
no other interference with any of them. The definite treatment strategy will be
based on currently applied strategies and guidelines and will not change due to
the study. All treatment decision will be done at operator discretion.
Anticipated risks for the patient
No additional risks for the patients are expected. This study does not
interfere with any common or generally used test or processes during the
work-up of CAD in any patient. No additional imaging or acquisition protocols
are mandatory. No additional radiation is warranted. The potential
risk for the patient applies to the known and common risks during the
diagnostic work-up process or during invasive coronary angiography (ICA) with
assessment of coronary microcirculation but are unrelated to this study.
Invasive functional assessment of the microcirculation has been
recommended as class IIa in INOCA according to the ACC/AHA Chest Pain
Guideline.
Industriezone Zuid III, Industrielaan 4
Erembodegem 9320
BE
Industriezone Zuid III, Industrielaan 4
Erembodegem 9320
BE
Listed location countries
Age
Inclusion criteria
Consecutive patients in whom physiological assessment of the microcirculatory
function including continuous coronary thermodilution has been performed with a
Pressure-wire X within the context of routine clinical care.
Exclusion criteria
. Age <18 years
2. Unable to provide written informed consent (IC)
3. Unstable hemodynamics
4. Ongoing chest pain
5. Previous CABG
6. Moderate to severe valvular heart disease
7. Uncontrolled or recurrent ventricular tachycardia.
8. Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times
the ULN.
9. Comorbidity with life expectancy <= 2 years.
10. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
11. Subject is currently participating in another investigational drug or
device clinical study.
12. Presence of other anatomic or comorbid conditions, or other medical,
social, or psychological conditions that, in the investigator's opinion, could
limit the subject's ability to participate in the clinical investigation or to
comply with follow-up requirements, or impact the scientific soundness of the
clinical investigation results.
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 |
|---|---|
| Other | Clintrials.gov nummer volgt, staat nog niet openbaar. |
| CCMO | NL83896.100.23 |