Vascular Interaction With Age in Myocardial Infarction

Status Completed

Clinical Trial Summary

The body produces a natural compound, nitric oxide (NO), which is known to improve the elasticity of blood vessels effect cardiac function and play a role in the remodeling process after a heart attack. The primary source of NO is one of the amino acids that the body uses to form new proteins, L-Arginine; although many individuals with heart disease also take medicines to increase the concentrations of NO such as nitroglycerine. The VINTAGE-MI trial is intended to investigate wether supplementation of the bodies supply of NO with oral administration of L-Arginine will improve the functional recovery of older patients who have recently suffered their first heart attack.

Clinical Trial Description

BACKGROUND:

As we age, both our blood vessels and heart muscle naturally become stiff and loose their ability to flex as the heart beats and blood pressure changes. This is believed to worsen both blood vessel and cardiac function in older individuals. The stiffened tissue is likely to be less able to adapt to the stresses and remodeling that occur after a heart attack (myocardial infarction) because the loss of functional heart tissue predisposes the heart to poor function and the hearts blood vessels undergo various changes in order to increase the supply of blood to the damaged areas.

DESIGN NARRATIVE:

VINTAGE-MI is a randomized, double blind study enrolling patients who have recently suffered their first heart attack. There are two recruitment clinics within the Johns Hopkins University Network, the Johns Hopkins Hospital and the Hopkins Bayview Medical Center. Following preliminary testing to establish eligibility and baseline function of both the heart and blood vessels, study participants will be randomly assigned to receive either L-Arginine or a placebo pill which is identical except that it does not contain L-Arginine. These pills will be taken orally 3 times a day for 6 months. Participants will return to the clinic 1, 3, and 6 months after they begin taking their medication to have the same functional testing repeated.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00051376
Study type	Interventional
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	N/A
Start date	September 2001
Completion date	August 2006

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.