Noninvasive Evaluation of Cardiac Allograft Vasculopathy

NCT01305382 | Withdrawn DMC

• 1 other identifier: 0808M43361
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal peripheral endothelial function and alterations in circulating biomarkers that are associated with endothelial activation and inflammation correlate with angiographic evidence of cardiac allograft vasculopathy, defined as greater than 25% stenosis in a major coronary artery.

Conditions

Cardiac Allograft Vasculopathy

Keywords

Cardiac Allograft Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Stenosis of a major coronary artery greater than 25% on coronary angiogram.

  The purpose of this study is to determine whether certain levels and patterns of expression of biomarkers known to be related to endothelial function and abnormalities in peripheral artery function are predictive of the presence of transplant vasculopathy.

  1 year

Study Arms (3)

Heart Transplant Cohort

This group consist of transplant subjects within 10 years of heart transplant

Heart Failure Sub group

Consist of subjects with advanced heart failure (NYHA class III and IV)

Healthy Volunteer

This groups consist of healthy individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Transplant subjects within 10 years of heart transplantation Subjects with advanced heart failure Healthy Volunteers

You may qualify if:

• Age ≥ 18 years
• Provide informed consent
• Presence of advanced heart failure (NYHA class III, IV) on medical therapy
• Patients with advanced heart failure on transplant list
• Transplant recipients undergoing invasive evaluation for coronary artery disease within 6 months to ten years post transplantation

You may not qualify if:

• Current tobacco use
• History of chronic kidney disease
• Active infection
• History of organ transplantation
• Diabetes Mellitus
• History of Hypertension
• Known coronary artery disease
• Connective tissue disorder
• History of hyperlipidemia
• History of Migraine or Chronic unevaluated headaches
• Patients with chronic kidney disease stage 4 defined as GFR\<30 mL/min/1.73 m2 or acute renal failure
• Patients with acute rejection, Grade 3A or greater
• Active infection
• Re-transplant or Multi-organ transplant recipient
• Surgery within 3 months prior to enrollment

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Cardiology Division, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Monica M Colvin-Adams, MD, MS

  Cardiology, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: October 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (1)