Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01076946 |
| Other study ID # |
pathophysiology TLVBS |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
February 25, 2010 |
| Last updated |
February 25, 2010 |
| Start date |
March 2010 |
| Est. completion date |
December 2010 |
Study information
| Verified date |
December 2009 |
| Source |
University Hospital, Gasthuisberg |
| Contact |
Peter Kayaert, MD |
| Phone |
+32 (0)16 34 09 26 |
| Email |
peter.kayaert[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
Belgium: ethics committee UZ Leuven |
| Study type |
Observational
|
Clinical Trial Summary
Transient left ventricular ballooning syndrome (TLVBS) is a cardiac syndrome that is
characterised by acute but transient left ventricular (LV) dysfunction.
Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as
originally thought, there is a need for further research into the etiology and
pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and
endothelial function in their population of TLVBS patients.
Description:
It was shown recently that in patients with previous TLVBS a cold pressor test (CPT) was
able to induce new mid-ventricular and apical wall motion abnormalities, similar to those in
the acute phase of the syndrome. Moreover, coronary blood flow (CBF), assessed by means of
myocardial contrast echocardiography (MCE), increased in a group of control subjects but not
in the TLVBS patients, suggesting a chronic impairment of coronary vasodilation reserve and
thus microvascular dysfunction.
Since the syndrome clearly is not a rare phenomenon and since prognosis is not as benign as
originally thought, there is a need for further research into the etiology and
pathophysiology of TLVBS. Therefore the investigators aim to study the microvascular and
endothelial function in their population of TLVBS patients. The project will be split up
into two parts:
1. From the patients that are already known in the prospective registry, patients willing
to participate after informed consent will be asked to undergo a "reactive hyperaemia -
pulse amplitude tonometry" (RH-PAT) baseline and after CPT and a cardiac magnetic
resonance scan (CMR), at least 3 months after the last TLVBS event.
The RH-PAT evaluates endothelial function. The CMR-evaluation at rest consists of
assessment of global and regional left ventricular function, the exclusion of
irreversible damage (lack of gadolinium hyperenhancement) and the evaluation of rest
perfusion. Subsequently, adenosine-induced hyperemia is induced by an infusion of 140
µg/kg/min adenosine for 3 to 4 minutes, with stress perfusion sequence starting at 3
minutes. After approximately 10 minutes, a CPT will be performed (180 seconds immersion
of the left foot in ice water (4°C)) immediately followed by a series of CMR cine
sequences and a second stress perfusion CMR sequence. Afterwards the RH-PAT examination
is repeated and blood sampling will be done for measuring plasma levels of B-type
natriuretic peptide (BNP), the catecholamines epinephrine, norepinephrine, and dopamine
and a marker for endothelial function endothelin-1.
Patients will be monitored for one hour and before discharge two-dimensional (2D)
echocardiography will be performed to exclude residual wall motion abnormalities. The
investigators goal is to include at least 30 patients in this protocol.
2. Patients who are newly admitted with TLVBS will follow a clinical path during index
hospitalisation including serial ECG recording, serial blood sampling of cardiac
biomarkers (Troponin I, CKMB), a sole sampling of BNP, catecholamines and endothelin-1,
a RH-PAT measurement, a 2D echocardiogram, a coronary angiogram and a CMR with rest
perfusion sequence. They will also be asked to return to the hospital at 3 months for
the evaluation mentioned above. Patients will be added to the prospective registry.
