Selective Coronary Vein Sampling in Left Bundle Branch Block and CRT
NCT ID: NCT02396875
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2015-04-30
2016-12-31
Brief Summary
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Detailed Description
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The study design will separate patients into a minimally invasive arm (MINARM)and an invasive arm (INARM). The INARM will be recruited from patients in the MINARM.
MINARM
Group 1: 40 patients scheduled for CRT implant Group 2: 15 patients with heart failure and no dyssynchrony Group 3: 15 patients with normal hearts
Group 1:
40 patient undergoing CRT will have venous samples taken from the CS, two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers
They will then undergo repeat sampling at 6 months to assess for changes in the micro RNA and biomarker profile including CS sampling.
Group 2 and 3
A control arm of 15 patients with heart failure and no dyssynchrony (Group 2) and 15 patients with normal hearts (Group 3) will undergo peripheral venous sampling for biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in micro RNA expression.
10 patient from Group 1 and 5 from Group 2 and 3 will be invited to from part of the INARM at the time of recruitment.
INARM study
Methods:
GROUP A 10 pts with heart failure and dyssynchronous ventricular contraction GROUP B 5 pts with heart failure and no electrical dyssynchrony schedule for either coronary angiography or electrophysiology study.
GROUP C 5 pts schedule for diagnostic coronary angiography or electrophysiology study with normal cardiac function
The exact details of the protocol will vary depending upon the Group:
GROUP A
1 On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.
3 6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further arterial access as described above. This study should take approximately an hour.
GROUP B and C
It is common practice for these patients to have a coronary angiogram to exclude ischaemic heart disease as the cause of their heart failure or chest pain or to have electrophysiology study to determine the mechanism of arrhythmia. If their angiogram is normal,we will perform a pacing protocol (this will be required if they are attending for an electrophysiology study). This will require 2 femoral venous access sites (similar to standard electrophysiological study) to allow temporary atrial pacing and acquisition of blood samples from the coronary sinus. Following the invasive part of the study patients in Group B and C will fall back into Group 2 and 3 of MINARM and attend at 6 month for peripheral blood sampling.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1
40 patients undergoing CRT will have venous samples taken from two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers They will then undergo repeat sampling at 6 months to assess for changes in the biomarker profile including CS sampling.
Central blood sampling pre and post CRT implant
Group 2
A control arm of 15 patients with heart failure and no dyssynchrony will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression.
Peripheral blood sampling
Group 3
A control arm of 15 patients with normal hearts will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression.
Peripheral blood sampling
Group A
10 patients from Group 1
On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. The patient will have a radial sheath positioned in the arterial system. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.
6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further study as described above.
Blood sampling and exercise protocol pre and post CRT implant
Group B
5 patients form Group 2.
Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 2 for 6 month follow up
Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling
Group C
5 patients form Group 3
Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 3 for 6 month follow up
Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling
Interventions
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Blood sampling and exercise protocol pre and post CRT implant
Peripheral blood sampling
Central blood sampling pre and post CRT implant
Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling
Eligibility Criteria
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Inclusion Criteria
-Scheduled for CRT implant
Group 2/B -Heart failure without electrical dyssynchrony.
Group B:
-Scheduled for angiography for clinical grounds
Group 3/C -Patients without known heart disease
Group C:
-Scheduled for clinical angiography and found to have normal coronary arteries
Exclusion Criteria
* Moderate to severe aortic valve disease
18 Years
ALL
Yes
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Guy's and St Thomas Hospital Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14/LO/1765
Identifier Type: -
Identifier Source: org_study_id
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