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OpenTrials
Completed

NCT Number: NCT00692991

Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures

Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. This study will use magnetic resonance imaging (MRI) procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure.

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Key information

About this study

CAD is the most common type of heart disease in the United States. It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries. Over time, less blood is able to flow through the arteries, depriving the heart of the blood and oxygen it needs. If left untreated, CAD can lead to heart failure, heart attack, and arrhythmias. Someone with plaque build-up may undergo a percutaneous coronary intervention (PCI) to unblock the narrowed arteries and increase blood flow. PCI encompasses a variety of procedures, including balloon angioplasty and stent placement. In balloon angioplasty, a small balloon is inserted into the heart artery and then inflated. This pushes the plaque against the artery walls and widens the artery. Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open. Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart, the tiny vessels of the heart may become blocked after these procedures, which may affect how the heart heals. This study will use MRI to examine heart function in people who have undergone PCI procedures. Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures, the factors that lead to the blockages, and how often blockages affect healing of the heart.

This study will enroll people who are undergoing a PCI procedure. Participants will undergo an MRI scan of the heart before and after the PCI procedure. During the 72 hours after the procedure, electrocardiogram (EKG) will be used to monitor heart electrical activity. At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later, participants will undergo an MRI, EKG, and blood collection. Study staff will call participants every 6 months for 5 years to collect medical information.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing diagnostic coronary angiography
  • Undergoing percutaneous coronary intervention

Exclusion criteria

  • Clinically unstable (i.e., demonstrates unstable cardiac rhythm or hemodynamics, supported on vasopressors or an intra-aortic balloon pump, and/or is actively ischemic) at the time of the MRI procedure
  • Unable to undergo MRI procedure (e.g., has non-MRI compatible implanted metallic objects, including cardiac pacemakers or cerebral aneurysm clips that are not MRI compatible)
  • Current glomerular filtration rate of less than 60mL/min/1.73m2
  • Pregnant

Treatment and study plan

Primary outcomes

  1. Prevalence of microvascular obstruction by MRI in participants who may or may not have had an acute heart attack; coronary angiographic correlates of MRI microvascular obstruction

    Time frame: Measured during participant's initial and follow-up MRIs

Secondary outcomes

  1. Relation of presence and extent of microvascular obstruction to clinical outcomes over 5 years

    Time frame: Measured every 6 months for 5 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Microvascular Obstruction by Contrast-enhanced MRI Following Percutaneous Coronary Interventions

Important dates

Study start
1999
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2008
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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