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Vascular Interaction With Age in Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00051376
First received: January 9, 2003
Last updated: May 5, 2006
Last verified: November 2005
  Purpose

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.


Condition Intervention
Myocardial Infarction
Drug: L-Arginine

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2001
Estimated Study Completion Date: August 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients will have suffered their first acute Q-wave MI within 3 to 21 days with creatine kinase levels 3 times normal. All patients will have systolic blood pressure over 100 mmHg and the permission of their attending physician and the ability to give voluntary informed consent. Patients will be excluded if they have had a prior Q-wave infarction, present cardiogenic shock, unstable angina or non-cardiac disease limiting life expectancy to less than 1 year. Other exclusion criteria include significant kidney or liver disease, uncontrolled diabetes, or symptomatic cerebrovascular disease (such as stroke). Patients who have been previously shown to be non-compliant will be asked not to participate.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051376

Sponsors and Collaborators
Investigators
Investigator: Steven Schulman Johns Hopkins University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00051376     History of Changes
Other Study ID Numbers: 154
Study First Received: January 9, 2003
Last Updated: May 5, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014