Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging

NCT02114697 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00059784
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess a slimy substance that settles/deposits along blood vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at risk of cardiovascular disease can have certain markers elevated in their blood that can be measured by simple blood tests. High or increased plaque deposition is seen in neck vessels of cancer patients who received radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are at increased risk of plaque development and are therefore called high-risk population. Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are one of the several fat lowering medications.

Conditions

Atherosclerosis

Keywords

Cancer survivorship; Cardiovascular disease; Stroke; Transient ischemic attack (TIA)

Outcome Measures

Primary Outcomes (1)

• Plaque Volume of Carotid Arteries

  Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm\^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.

  Baseline, 18 months, 36 months

Study Arms (2)

Lifestyle modification

ACTIVE COMPARATOR

Lifestyle modification is tailored to each participant and includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake.

Behavioral: Lifestyle modification

Statin therapy

EXPERIMENTAL

Participants will receive statin medication along with instruction about regular exercise.

Drug: Statin therapy

Interventions

Statin therapy DRUG

Statin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement.

Also known as: Crestor

Statin therapy

Lifestyle modification BEHAVIORAL

Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.

Lifestyle modification

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 and above with prior head and neck or chest irradiation
• Six months or more post head and neck irradiation
• Documented subclinical cardiovascular disease (inflammatory markers in the serum)
• Pre-existing plaques (detected by ultrasound, CT or MRI)
• Asymptomatic major arterial stenosis
• Not being considered for arterial surgery or endovascular treatment.

You may not qualify if:

• Recurrence of cancer (with or without treatment)
• Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
• Renal failure
• Estimated glomerular filtration rate (eGFR) \< 45 (calculation based on serum creatinine levels, race, age and gender)
• Medically unstable or hematologic, renal, or hepatic dysfunction
• Non-atherosclerotic arterial stenosis (dissection)
• Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
• Contraindications to MRI: cardiac pacemaker, metal implants, metal in eyes, pregnant or nursing women, claustrophobia, allergy to MRI contrast
• Physical or mental impairment that would limit the patient's ability to comply with the medical instructions or study procedures

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

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MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Stroke; Ischemic Attack, Transient

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: John Oshinski PhD
• Organization: Emory University

jnoshin@emory.edu

404-727-5894

Study Officials

• John Oshinski, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The protocol originally specified randomizing participants to a study arm, but the protocol was amended to clarify that a participant's cardiologist could change the treatment regimens that participants were assigned to so that no participant was restricted from statin therapy.

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 11, 2018
• Results First Posted: August 14, 2018

Record last verified: 2018-08

Locations

US (1)