ISRCTN - ISRCTN56034553: PREVEC Trial: Prevention of Reperfusion damage associated with percutaneous coronary angioplasty following acute myocardial infarction

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ramón Rodrigo

ORCID ID

Contact details

Independencia 1027
Santiago
8380453
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1120594

Study information

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

Acronym

PREVEC

Study hypothesis

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

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

Study design

Randomized double-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please contact Dr. Ramón Rodrigo [rrodrigo@med.uchile.cl] to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

04/02/2013

Overall trial end date

31/03/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

132

Participant 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

Recruitment start date

04/02/2013

Recruitment end date

31/03/2016

Locations

Countries of recruitment

Chile

Trial participating centre