Contact information
Type
Scientific
Contact name
Dr Kunadian Vijayalakshmi
ORCID ID
Contact details
The James Cook University Hospital
Cardiothoracic Department
Marton Road
Middlesbrough
Cleveland
TS4 3BW
United Kingdom
+44 (0)1642 282410
Kunadianvijay@aol.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0227164222
Study information
Scientific title
Acronym
Study hypothesis
To study if the use of verapamil and adenosine will result in improved blood flow through the heart arteries, assessed by the TIMI frame count.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Urological and Genital Diseases: Angiography and/or angioplasty
Intervention
Patients undergoing coronary angiography with a view to urgent or emergency angioplasty will be consented and will be given a patient information leaflet. Patients will be randomised if their coronary arteries show evidence of the slow-flow phenomenon and all patients undergoing angiography and/or angioplasty in the setting of an acute coronary syndrome will also be randomised. Normal saline, verapamil or adenosine will be administered and pictures of the heart arteries will be taken. At the end of the procedure the TIMI frame count (number of picture frames required for the dye to travel from the top end of the artery to the bottom end) will be calculated.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
verapamil and adenosine
Primary outcome measure
1. Improvement in TIMI frame count.
2. Post-procedural left ventricular function (measured by echocardiography).
3. Speed and extent of ST segment recovery.
4. Cardiac enzyme measurements.
Secondary outcome measures
Not provided at time of registration
Overall study start date
07/05/2003
Overall study end date
07/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
35 in each group, total 105 patients undergoing angiography and/or angioplasty in the setting of an acute coronary syndrome.
Patients will be randomised if their coronary arteries show evidence of the slow-flow phenomenon and all patients undergoing angiography and/or angioplasty in the setting of an acute coronary syndrome will also be randomised.
Patients who are listed for elective or emergency angiography and/or angioplasty will be suitable for the study.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
105
Participant exclusion criteria
1. Asthmatics
2. Patients with renal impairment
3. Those with left main stem disease
4. Patients with a BP<90mmHg and with a heart rate of >100 bpm
5. Patients with heart block
Recruitment start date
07/05/2003
Recruitment end date
07/05/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
The James Cook University Hospital
Cleveland
TS4 3BW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No |