Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
05/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

verapamil and adenosine

Primary outcome measures

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 trial start date

07/05/2003

Overall trial end date

07/05/2004

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16449518

Publication citations

  1. Results

    Vijayalakshmi K, Whittaker VJ, Kunadian B, Graham J, Wright RA, Hall JA, Sutton A, de Belder MA, Prospective, randomised, controlled trial to study the effect of intracoronary injection of verapamil and adenosine on coronary blood flow during percutaneous coronary intervention in patients with acute coronary syndromes., Heart, 2006, 92, 9, 1278-1284, doi: 10.1136/hrt.2005.075077.

Additional files

Editorial Notes