A prospective, randomised, controlled trial to study the effect of verapamil and adenosine on the TIMI frame count
| ISRCTN | ISRCTN44611940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44611940 |
| Secondary identifying numbers | N0227164222 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 05/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kunadian Vijayalakshmi
Scientific
Scientific
The James Cook University Hospital
Cardiothoracic Department
Marton Road
Middlesbrough
Cleveland
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 282410 |
|---|---|
| Kunadianvijay@aol.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 07/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 105 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 07/05/2003 |
| Date of final enrolment | 07/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The James Cook University Hospital
Cleveland
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Tees Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No |
