PREVEC Trial: Prevention of Reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction

ISRCTN	ISRCTN56034553
DOI	https://doi.org/10.1186/ISRCTN56034553
Secondary identifying numbers	1120594

Submission date: 21/01/2013
Registration date: 28/01/2013
Last edited: 03/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Acute myocardial infarction (AMI) is the leading cause of mortality in Chile and worldwide. It
also has negative effects on quality of life in survivors.
Existing treatments have reduced mortality. But they have the side effect of restoring the blood flow to the heart which is called an ischemia-reperfusion event. Ischemia-reperfusion increases heart damage through a process called oxidative stress. Ischemia reperfusion damage may be preventable. The aim of the study is to assess whether increasing the antioxidant defences will decrease heart damage. This will be done by giving antioxidant vitamin C (intravenously) and vitamin E (orally) to acute myocardial infarction patients during the standard procedure for AMI called percutaneous coronary angioplasty.

Who can participate?
Patients of either sex, over 18 years old, with an indication of primary percutaneous coronary angioplasty and experiencing their first acute myocardial infarction (symptoms must have started during the last 12 hours).

What does the study involve?
Patients will be randomly allocated to one of two groups. One group (Vitamin-treatment group) will receive the standard procedure for an acute myocardial infarction plus a high-dose infusion of vitamin C and an oral dose of vitamin E.
The other group (Control Group) will receive the standard procedure for an acute myocardial infarction plus an infusion of a harmless substance (saline solution) instead of vitamin C and a harmless oral dose of vegetal oil.
Patients in both groups will give blood at entry, during the intervention procedure and at discharge. Cardiac magnetic resonance assessment will be performed 6 and 84 days after the procedure.

What are the possible benefits and risks of participating?
For the Vitamin-treatment group, it is possible that the infarct size in the heart is reduced in comparison to the Control group. Benefits for the Control group are a longer follow-up by the medical team. Possible reported side effects in the Vitamin-treatment group are lethargy or fatigue (0.17% of patients) and/or phlebitis (0.05% of patients).

Where is the study run from?
The University of Chile Clinical Hospital, Cardiovascular Department (Chile).

When is the study starting and how long is it expected to run for?
The study will start in February 2013 and will run for 3 years or until the required number of
132 patients have been treated and evaluated.

Who is funding the study?
The Scientific and Technological Development Fund (FONDECYT) - Chilean Government

Who is the main contact?
Dr Ramon Rodrigo
rrodrigo@med.uchile.cl

Contact information

Dr Ramón Rodrigo
Scientific

Independencia 1027
Santiago
8380453
Chile

Study information

Study design	Randomized double-blind placebo-controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please contact Dr. Ramón Rodrigo [rrodrigo@med.uchile.cl] to request a patient information sheet
Scientific title	PREVEC Trial: Prevention of Reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction: a randomized double-blind placebo-controlled clinical trial
Study acronym	PREVEC
Study objectives	Patients subjected to percutaneous coronary angioplasty to restore the coronary blood flow previously impaired by an acute myocardial infarction, while receiving a short-term infusion of high doses of vitamin C, plus oral doses of the recommended dose of vitamin E, will present a lower infarct size, as well as an attenuation of the functional and biochemical damage occurring during the reperfusion following to the sudden loss of blood supply, as compared with placebo-treated patients.
Ethics approval(s)	Local Ethics Committees (University of Chile Clinical Hospital, Faculty of Medicine of the University of Chile and Health Ministry of the Chilean Government), 07/2011, ref: Project number - 06-2011
Health condition(s) or problem(s) studied	Acute Myocardial Infarction
Intervention	Intervention: Short term massive infusion of intravenous vitamin C (320 mmol/L) Oral dose of vitamin E (400 IU/day) throughout the protocol Oral dose of vitamin C (500 mg/12 hours) following angioplasty, throughout the protocol Control: Placebo
Intervention type	Other
Primary outcome measure	Infarct size, assessed by cardiac magnetic resonance (CMR) will be measured twice: 6 and 84 days following coronary angioplasty
Secondary outcome measures	Biomarkers for oxidative stress, antioxidant status, heart damage and inflammation will be measured at baseline, at the onset of reperfusion, 6-8 hours after revascularization and at hospital discharge.
Overall study start date	04/02/2013
Completion date	31/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	132
Key inclusion criteria	1. Subjects may be of either sex and must be at least 18 years old 2. Subjects must have indication of primary percutaneous coronary angioplasty (PCA) as follows: 2.1. Angina or equivalent at least 120 min duration 2.2. Electrocardiogram (ECG) with STEMI that concerns more than 2 contiguous leads (>2mm) 3. Presentation within 12 h of symptoms onset 4. First myocardial infarction 5. Subject must be able and willing to sign informed consent
Key exclusion criteria	1. History of renal or hepatic insufficiency 2. History of renal lithiasis (oxalates) 3. History of heart failure (NYHA III, IV) 4. Cardiogenic shock 5. Any serious medical co-morbidity that determine life expectancy < 6 month 6. Current participation in any other clinical investigation 7. Pregnancy 8. Glucose 6-phosphate dehydrogenase deficiency
Date of first enrolment	04/02/2013
Date of final enrolment	31/03/2016

Locations

Countries of recruitment

Chile

Study participating centre

Independencia 1027

Santiago
8380453
Chile

Sponsor information

Scientific and Technological Development Fund (FONDECYT Fondo de Desarrollo Científico y Tecnológico) (Chile)
Government

c/o Maria Elena Boisier
Bernarda Morin 551
Providencia
Santiago
8380453
Chile

Phone	+56 2 2 365 44 00
Email	fondecyt@conicyt.cl
Website	http://www.fondecyt.cl/
"ROR"	https://ror.org/02ap3w078

Funders

Funder type

Government

Scientific and Technological Development Fund (FONDECYT) (Chile) grant number 1120594.

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?
Protocol article	protocol	29/05/2014		Yes	No