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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN44611940 |
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Date of registration:
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29/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A prospective, randomised, controlled trial to study the effect of verapamil and adenosine on the TIMI frame count
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Scientific title:
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Date of first enrolment:
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07/05/2003 |
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Target sample size:
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105 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN44611940 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Kunadian
Vijayalakshmi |
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Address:
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The James Cook University Hospital
Cardiothoracic Department
Marton Road
Middlesbrough
TS4 3BW
Cleveland
United Kingdom |
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Telephone:
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+44 (0)1642 282410 |
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Email:
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Kunadianvijay@aol.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Urological and Genital Diseases: Angiography and/or angioplasty
Urological and Genital Diseases
Angiography and/or angioplasty
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0227164222
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Source(s) of Monetary Support
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South Tees Hospitals NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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