Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051376
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2003-01-09
Brief Title:
Vascular Interaction With Age in Myocardial Infarction
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070059 | NIH | None | httpsreporternihgovquickSearchR01HL070059 |