Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001020673
Ethics application status
Approved
Date submitted
12/09/2014
Date registered
23/09/2014
Date last updated
7/04/2024
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational cohort study of serial blood sampling to measure the levels of biomarkers expressed prior to and after transcoronary ablation of septal hypertrophy (TASH).
Scientific title
SErial biomArker profiling in tRansCoronary ablation of septal Hypertrophy
Secondary ID [1] 285325 0
nil
Universal Trial Number (UTN)
U1111-1157-8380
Trial acronym
The SEARCH Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 293047 0
Condition category
Condition code
Cardiovascular 293321 293321 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing transcoronary ablation of septal hypertrophy (TASH) will be invited to participate in an observational cohort study of serial blood sampling to measure the levels of biomarkers expressed prior to and after the procedure.

The TASH procedure is the perfect human model of acute myocardial infarction (AMI) with the onset of cardiac injury known to the second. Measurement of new high sensitivity troponin assays (hsTnT and hsTnI) and other candidate early markers like copeptin, Brain Natriuretic Peptide signal peptide (BNPsp) and circulating microRNA and DNA in serial blood samples will be performed to determine the earliest and most informative biomarkers in the first minutes to hours after onset of coronary ischaemic injury. High end lipidomic and other metabolomic analysis will also be applied and analysed. These analyses will be performed in order to better understand the biochemical response to TASH and to identify prognostic markers that may be useful in predicting outcomes.
The overall duration of observation is from immediately prior to surgery and for 24 hours afterwards.
As per usual clinical care and procedure, septal ablation occurs via temporary septal artery branch occlusion and injection of 1ml 100% ethanol after heparin administration (bolus, 5000 IU heparin).
Intervention code [1] 290236 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293148 0
Serum Brain Natriuretic Peptide signal peptide (BNPsp) as assessed using an immunoassay.
Timepoint [1] 293148 0
Samples will be taken at 10 minutes, +15, +30, +45, +60, +120, +240 and +1440 minutes after ethanol administration.
Primary outcome [2] 293149 0
Novel Natriuretic Peptides peptide as assessed using an immunoassay.
Timepoint [2] 293149 0
From blood samples taken at 10 minutes, +15, +30, +45, +60, +120, +240 and +1440 minutes after ethanol administration
Primary outcome [3] 293150 0
Evaluate the well documented temporal rise of cardiac troponin as a reference using a serum immunoassay.
Timepoint [3] 293150 0
Blood samples will be taken at 10 minutes, +15, +30, +45, +60, +120, +240 and +1440 minutes after ethanol administration.
Secondary outcome [1] 310453 0
nil
Timepoint [1] 310453 0
nil

Eligibility
Key inclusion criteria
Patients admitted for a septal ablation procedure in the Cardiac Catheter Lab
Ability to provide informed written consent.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical contraindications to invasive angiography or percutaneous procedures.
Inability to sign informed consent
Unwilling to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Up to 50 consecutive patients with hypertrophic obstructive cardiomyopathy (HOCM) undergoing septal ablation will be included. As this is an observation case series study design based on similar studies of biomarker kinetics statistical assumptions supporting sample size calculations, e.g. effect size to be detected, statistical power are not necessary .The methodology has been well tested in studies of earlier generation biomarkers. The outcome will be the identification of potential new biomarkers that can more accurately and rapidly identify patients suffering a myocardial infarction, thereby facilitating more expeditious treatment and facilitating outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
10/11/2014
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 6351 0
New Zealand
State/province [1] 6351 0
Christchurch

Funding & Sponsors
Funding source category [1] 289945 0
Charities/Societies/Foundations
Name [1] 289945 0
Christchurch Heart Institute
Country [1] 289945 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Christchurch Heart Institute
Address
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 288635 0
None
Name [1] 288635 0
Address [1] 288635 0
Country [1] 288635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291659 0
NZ Health & Disability Ethics Committee
Ethics committee address [1] 291659 0
C/- MEDSAFE, Level 6, Deloitte House.
10 Brandon Street,
PO Box 5013.
Wellington.
6011.
Ethics committee country [1] 291659 0
New Zealand
Date submitted for ethics approval [1] 291659 0
09/06/2014
Approval date [1] 291659 0
24/09/2014
Ethics approval number [1] 291659 0
14/STH/73

Summary
Brief summary
The principle hypothesis of this study proposal is that the clinical procedure of septal ablation (TASH) offers the most accurate and controlled circumstance of acute cardiac injury, mimicking a myocardial infarction. As the precise time of myocardial cell death can be documented, this then allows precise temporal profiling of novel markers that could be used to make further improvements in the diagnosis and management of heart attacks, as they present in "real world" clinical experience.

This study will identify rapidly responding biomarkers that are specific to myocardial infarction. Knowledge of these markers and their temporal profile can then be applied to future clinical studies directly assessing their potential to be applied in an emergency department setting to assist in the rapid, accurate identification of patients suffering
acute coronary syndromes.

Consecutive patients (up to n=50) with hypertrophic obstructive cardiomyopathy (HOCM) undergoing septal ablation will be included. As per usual clinical care and procedure, septal ablation occurs via temporary septal artery branch occlusion and injection of 1ml 100% ethanol after heparin administration (bolus, 5000 IU heparin). Postprocedural management included monitoring at the intensive care unit for 48 hours.

All patients will be provided with complete study information before being asked to provide consent. Blood samples (10ml serum and 10ml EDTA) will be taken at each time point given, ie. 20ml per time point. Samples will be taken at 10 minutes, +15, +30, +45, +60, +120, +240 and +1440 minutes after ethanol administration. Samples will be drawn at each time point from a forearm
antecubital vein. Cardiac coronary sinus samples will be taken at 10 and +15 minutes only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51398 0
Dr John Lainchbury
Address 51398 0
Cardiology Department
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country 51398 0
New Zealand
Phone 51398 0
+643 364 0640
Fax 51398 0
+643 364 1115
Email 51398 0
john.lainchbury@cdhb.health.nz
Contact person for public queries
Name 51399 0
Ms Lorraine Skelton
Address 51399 0
Christchurch Heart Institute
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country 51399 0
New Zealand
Phone 51399 0
+643 364 1063
Fax 51399 0
+643 364 1115
Email 51399 0
lorraine.skelton@cdhb.health.nz
Contact person for scientific queries
Name 51400 0
A/Prof Chris Pemberton
Address 51400 0
Christchurch Heart Institute
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country 51400 0
New Zealand
Phone 51400 0
+643 3640887
Fax 51400 0
+643 3641115
Email 51400 0
chris.pemberton@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.