Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility

NCT06412536 | Recruiting

• 1 other identifier: CORE042024
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

SWIFT-CORE-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. Site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. A doctor will review medical history with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials.

Conditions

Cardiovascular Diseases; Obesity; PreDiabetes; Diabetes Type 2; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of participants who are interested in industry-sponsored clinical research

  Number of participants who are interested in industry-sponsored clinical research in each of the following therapeutic areas: cardiovascular, obesity, and endocrine.

  5 years

Secondary Outcomes (1)

• Characteristics associated with patient populations interested in clinical trials

  5 years

Interventions

Blood work OTHER

Blood work on some participants to review eligibility for future clinical trials

Eligibility Criteria

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

Study Population

In year one of the program, we anticipate 4000 participants of any sex, age 18+, who have expressed interest in participating in an industry-sponsored clinical trial of an investigational product for indications in cardiovascular, obesity, and endocrine-related therapeutic areas will be screened for clinical appropriateness for a study trial.

You may qualify if:

• Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
• Participant is at least 18 years old.

You may not qualify if:

• Participant is pregnant, breast-feeding, or planning to become pregnant.
• History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
• Moderate or severe substance use disorder within 90 days prior to screen
• Any condition that in the investigator's opinion makes a participant unsuitable for the study.
• Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.

Sponsors & Collaborators

• Brooklyn Clinical Research: lead

Study Sites (1)

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Prediabetic State; Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Ammara Mushtaq, MD

  Brooklyn Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ammara Mushtaq, MD

CONTACT

929-203-5879; amushtaq@brooklynclinicalresearch.com

Katherine Azer, MS

CONTACT

929-332-7848; kazer@brooklynclinicalresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 17, 2029
• Last Updated: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)