The primary objective of the registry is:To analyse coronary artery disease progression with or without coronary artery bypass grafting.The secondary objective of the registry is:To report graft patency following bypass grafting of diffusely…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease progression and plaque burden. Patients will undergo a CT scan at
baseline and at 1-year follow-up in order to estimate coronary calcification
with the Agatston score and to analyse the progressions of stenotic lesions
with a not pre-specified selection of methods.
Secondary outcome
Graft patency. Patients undergoing CABG will receive a baseline and follow-up
(at 1-year) CT scan. There is no pre-specified scanning protocol.
Background summary
Coronary artery bypass grafting is a long-lasting treatment for symptomatic
obstructive coronary artery disease. It is the treatment of choice in the
presence of complex and extensive stenotic lesions and many consider it an
attractive option for patients with diffusely diseased coronary arteries. What
makes it appealing is the durability and disease-prevention capability of
arterial grafts. Internal mammalian artery (IMA) grafts have 1-year mortality
rates of 1.1%-4.5% (11-13) and 1-year MACE rates of ~3%-15%. Unfortunately,
asymptomatic graft occlusion may be more common, and graft durability may
decrease in the presence of diffuse coronary artery disease. In some cases LIMA
failure may be as high as 7%-26%, with 26% observed in a special subset of
diffusely diseased LAD*s. On the other hand, the evidence supporting the
protective effects of mammalian arteries is growing but it remains unclear what
its added value is when compared to state-of-the-art medical treatment.
The popularity of pharmacological management is rising, as several studies have
failed to verify a mortality benefit after myocardial revascularization. This
could be a result of recent developments in angina treatment and event
prevention. Not surprisingly, percutaneous and surgical interventions are more
and more often delayed or avoided, especially in asymptomatic patients.
Study objective
The primary objective of the registry is:
To analyse coronary artery disease progression with or without coronary artery
bypass grafting.
The secondary objective of the registry is:
To report graft patency following bypass grafting of diffusely diseased left
anterior descending arteries.
To compare methods for plaque progression analysis.
Study design
Prospective multicenter real-world registry.
Study burden and risks
Applied treatments (pharmacological, interventional and surgical) are part of
the current clinical practice. Contemporary CT scan protocols make use of
radiation (1,5mSv) and contrast injection. According to the FDA the additional
radiation risk is quite low.
H. Dunantstraat 5
Heerlen 6419PC
NL
H. Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
Inclusion criteria
Stable coronary artery disease OR Hemodynamically stable patients with a
Non-STE Acute Coronary Syndrome
Hemodynamically significant, diffuse LAD disease with involvement of the
proximal segment (MEDINA 0.1.0 left main lesions allowed).
Age >= 18.
Signed informed consent.
Ability to tolerate and no plans to interrupt relevant medical treatment during
the duration of the study and willing to comply with protocol required
follow-up.
Exclusion criteria
Previous CABG
Prior anterior myocardial infarction with clear evidence of residual akinesia
and/or dyskinesia
Extremely diseased LAD precluding intracoronary diagnostics or bypass grafting.
Renal dysfunction (GFR <30 ml/min/1.73m2)
Known contrast allergy
Severe aortic valve stenosis and/ or mitral valve regurgitation
Planned major surgery within the next 12 months
Extra-cardiac illness that is expected to limit survival to less than 1 year.
Pregnancy, planned pregnancy within the follow-up period, breastfeeding.
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 | NL84974.096.23 |