Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility (SWIFT-CORE-101)

Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility (SWIFT-CORE-101)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Obesity; Metabolic Syndrome; PreDiabetes; Diabetes Type 2
• Intervention / Treatment: Other: Blood work

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Ammara Mushtaq, MD; Phone Number: 929-203-5879; Email: amushtaq@brooklynclinicalresearch.com
• Study Contact Backup: Name: Katherine Azer, MS; Phone Number: 929-332-7848; Email: kazer@brooklynclinicalresearch.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11226
      • Recruiting
      • Brooklyn Clinical Research
      • Contact: Ammara Mushtaq, MD; Phone Number: 929-203-5879; Email: amushtaq@brooklynclinicalresearch.com
      • Principal Investigator: Ammara Mushtaq, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Participant is pregnant, breast-feeding, or planning to become pregnant.
2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
3. Moderate or severe substance use disorder within 90 days prior to screen
4. Any condition that in the investigator's opinion makes a participant unsuitable for the study.
5. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics associated with patient populations interested in clinical trials	Characteristics associated with patient populations interested in clinical trials stratified by demographics and therapeutic areas	5 years

Collaborators and Investigators

• Sponsor: Brooklyn Clinical Research
• Investigators: Principal Investigator: Ammara Mushtaq, MD, Brooklyn Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 17, 2029

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity; Metabolic Syndrome
• Other Study ID Numbers: CORE042024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No